Avoid Using Adenosine Needleless Prefilled Glass Syringes in Emergencies
FDA today urged personnel who stock crash carts, ambulances, and emergency rooms to furnish them with adenosine in vials or prefilled plastic syringes, not needleless prefilled glass syringes.
Insertion of a needleless prefilled adenosine glass syringe into a pin-activated needleless i.v. access system can cause the pin to clog or break off in the syringe's tip, FDA said.
The resultant damage can prevent delivery of the medication, which is used to restore normal sinus rhythm in patient s with paroxysmal supraventricular tachycardia. FDA said the syringe may even damage the i.v. tubing or the needleless access system to the extent that health care personnel must again establish i.v. access in the patient.
The agency first alerted health care professionals to the problem, also involving needleless prefilled amiodarone glass syringes, last November.
But FDA said it continued to receive reports of the needleless prefilled glass syringes clogging and malfunctioning.
Sagent Pharmaceuticals Inc., the supplier of the amiodarone syringes, recalled all lots in March. The company said prefilled amiodarone syringes will not be available until the incompatibility between the syringes and the i.v. sets is solved.
FDA said no company has recalled its adenosine needleless prefilled glass syringes because, at present, there are not enough adenosine vials to serve as replacements.
The agency has identified the following i.v. access systems as incompatible with adenosine and amiodarone needleless prefilled glass syringes: Clave and Microclave connectors, manufactured by ICU Medical Inc.; and LifeShield Clave and Microclave connectors, distributed by Hospira Inc.