The company received complaints regarding the syringes in the kits that revealed dural puncture with some also requiring a blood patch. An inadvertent dural puncture may lead to headache, tinnitus and (rarely) intracranial hemorrhage, according to the safety notice.
According to the notice, the syringe may be blocked or sticking, which could lead to a false-negative result. A syringe leak is also possible, which could lead to a false-positive result, which could then result in catheter misplacement. There is potential for the inadvertent administering of an inappropriate dose of a local anesthetic to the subarachnoid space, which could result in permanent spinal cord injury.
Users of the kits are urged to cease use and distribution of the affected products immediately and return all products to Teleflex.
Wayne, Pa.–based Teleflex just last month issued a safety warning in the United Kingdom for its Arrow EZ-IO intraosseous vascular access needle sets due to a risk of needle stick injury.