ISSUE: FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, often when attempting to connect to some pin activated needleless IV access systems. Adenosine is a cardiac drug that is administered when a patient has a rapid or irregular heart rhythm in an attempt to return their heart rhythm to normal. Adenosine must be injected rapidly into the blood stream in emergency situations and this failure could delay treatment.
In some cases where an attempt is made to connect to pin activated needless IV access systems, the syringe may cause the pin to break thus clogging the syringe, or damaging the IV tubing and/or the needleless connector and requiring reestablishment of a new intravenous access. These failures can cause a delay in administration of the medication, which could potentially result in serious harm to patients.
BACKGROUND: Adenosine pre-filled glass syringes are marketed by Teva, Sagent, Baxter, and Wockhardt. FDA has also received reports of problems related to certain pre-filled needleless glass syringes containing the cardiac drug amiodarone. See the FDA letter for a list of affected adenosine and amiodarone products.
RECOMMENDATION: Healthcare professionals, risk managers, and staff who purchase, stock, or administer emergency crash cart medications, operating room medications, emergency drug boxes, or types of emergency drug caches should be alerted to this incompatibility problem and potential for damage or blockage of the IV line and delay in administering the medication. Healthcare organizations currently using glass prefilled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes as a back up measure.
FDA has expanded the scope of its review to include all currently marketed pre-filled needleless glass syringes intended for use with needleless intravenous access systems, where delay in administration could potentially result in a life threatening event. FDA is working with manufacturers to correct the problem and identify additional mitigation strategies.
Healthcare professionals and healthcare organization managers are encouraged to report adverse events or problems experienced with the use of needleless pre-filled glass syringes to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. FDA is interested in receiving information on the type, manufacturer and NDC numbers of the prefilled syringes and type and manufacturer of needless IV access devices. FDA is especially interested in any description of the nature of the syringe failure, any adverse patient outcomes, and any mitigation strategies that have been identified or implemented by users of these products.
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[11/17/2010 - Letter to Stakeholders - FDA]