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
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
- 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.