8/31/10
Huber Needles: Recall - Risk of Coring
The Food and Drug Administration (FDA) notified healthcare professionals of the Class I Recall of certain Huber needles that were determined by FDA testing to produce cores when inserted into ports. Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core traveling through blood vessels into the patient’s lungs. These issues may potentially cause death.
Following hospital reports to the FDA of leakage after accessing the port with a Huber needle (labeled to be noncoring), FDA conducted its own laboratory testing of Huber needles from multiple manufacturers. Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane. The defect in the port as a result of coring can cause the ports to leak. The core can also potentially enter a patient’s body when the port is initially accessed if it is not flushed correctly. For more information, click here.
Needlestick Injury Due to Label Issue with Lovenox Unit Dose Injection
The Institute for Safe Medication Practices (ISMP) received a report about a nurse at a large health system who was stuck by a needle on a commercially prepared Lovenox (enoxaparin) prefilled syringe (Sanofi-aventis). The manufacturer’s label that was placed around the barrel of the syringe did not fully adhere. The needlestick occurred after the nurse had given the patient the injection. Upon removal of the needle from the patient’s skin and just before the built-in safety shield could be engaged, the adhesive caught the nurse’s glove and twisted the syringe, allowing the needle to stick her. To continue the story, click here.
A.S.P.E.N. Announces Intravenous Fat Emulsion Shortage
There is currently an intravenous fat emulsion (IVFE) shortage in the U.S. due to a temporary decrease in market supply and it is not clear when the supply will return to normal levels. The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) has assembled a group of experts to develop clinical recommendations for IVFE usage during this shortage. A.S.P.E.N. is also in constant communication with the two U.S. IVFE suppliers and will continue to monitor the market and provide further information as this situation changes. For more information, click here.
WARNING: RISK FOR SERIOUS
OR FATAL MEDICATION ERROR
A National Alert Network message from the American Society of Health-System
Pharmacists and the Institute for Safe Medication Practices
EPINEPHrine pre-filled syringe shortage
EPINEPHrine emergency syringes 1 mg/10 mL (0.1 mg/mL) are currently on backorder from the sole manufacturer of this product. Although the shortage is expected to resolve later this summer, practitioners should be aware of risk for error created by the shortage. For more information, click here.
Hospira Brand Liposyn and Propofol: Recall
Propofol Injectable Emulsion 1%, Liposyn (Intravenous Fat Emulsion) Products Including Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%
Hospira notified healthcare professionals of a voluntary recall of several injectable products because some of the containers may contain particulate matter, primarily made up of subvisible inert stainless steel particles. Since these particulate contaminants do not dissolve in blood, they could potentially act as emboli and impede blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death. For more information, click here.
Intravenous Medications Manufactured by Claris: Recall due to contamination of products
Metronidazole, Ciprofloxacin and Ondansetron sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.
Audience: Pharmacists, Hospital Risk Managers
FDA notified healthcare professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product. Healthcare professionals should not use these products and should immediately remove them from their pharmacy inventories. Claris is initiating a recall of all lots of these products. FDA is further investigating the situation and will notify the public when new information becomes available. Please review the linked Public Health Alert for a list of the affected and recalled products.
Read the complete MedWatch 2010 Safety summary, including a link to the Public Health alert here.
Baxter Announces Voluntary Recall of All Manufactured Lots of Hylenex Recombinant
Baxter International Inc. announced a voluntary recall of all manufactured lots of Hylenex recombinant (hyaluronidase human injection). The recall has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing. To date, no medical events or customer complaints associated with this issue have been reported. As part of this stability testing for Hylenex recombinant, a limited number of vials were observed to contain small, flake-like particles, identified as glass. The company estimates that there are approximately 3,500 vials in the marketplace.
Baxter is working with the product's NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue and appropriately address the situation. For more information, click here.
Metronidazole Injection 500 mg /100 mL: Voluntary Recall Due to Nonsterility
Sagent Pharmaceuticals, Inc., announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500 mg /100mL manufactured by Claris Lifesciences and distributed by Sagent due to the discovery of nonsterility in two lots of metronidazole injection. Nonsterility of an antimicrobial administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation. For more information, click here.
Baxter Colleague Infusion Pumps: FDA Ordering Recall
The Food and Drug Administration ( FDA ) notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use. FDA is ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers. For more information, click here.
FDA Allows Use of Recalled Infusion Pumps During Transition
In a letter to healthcare professionals, the US Food and Drug Administration (FDA) today advised healthcare providers that they may continue to use Colleague Volumetric Infusion Pumps manufactured by the Baxter Healthcare Corp. while it works with the company to develop an "orderly transition plan." In a letter to the company, the agency also ordered Baxter to provide refunds to customers or replace pumps at no cost. For more information, visit the Questions and Answers posted at www.fda.gov.
Food and Drug Administration Issues Draft Guidance on Infusion Pumps
The Food and Drug Administration (FDA) has seen an increase in the number and severity of infusion pump recalls. To address this issue, the FDA has developed a guidance document to assist industry in preparing premarket notification submissions for infusion pumps and to identify device features that manufacturers should address throughout the total product life cycle. The recommendations are intended to improve the quality of infusion pumps in order to reduce the number of recalls and infusion pump Medical Device Reports (MDRs).
