BD NEEDLE

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: T WAS REPORTED THAT, "SPINAL ANESTHESIA FOR A HIP SURGERY. WHEN THE SPINAL NEEDLE IS IN PLACE IN THE SPINAL SPACE AND THE LUER LOCK SYRINGE (BD SKU 309658) WITH THE MEDICATION IS TO BE CONNECTED, IT IS DISCOVERED THAT THERE IS A CRACK IN THE PLASTIC AT THE CONNECTION, PREVENTING THE NEEDLE AND SYRINGE FROM CONNECTING PROPERLY. THE MEDICATION IS ADMINISTERED, BUT SOME LEAKS OUT TO THE SIDE, SO THE TOTAL VOLUME DELIVERED INTO THE SPINAL SPACE IS NOT ENTIRELY PRECISE. HOWEVER, IT TAKES EFFECT AS INTENDED. THE USED SPINAL NEEDLE AND SYRINGE ARE AVAILABLE AS SAMPLES. PHOTO ATTACHED OF THE PRODUCTS: THE SYRINGE AND THE SPINAL NEEDLE WITHOUT PACKAGING ARE THE ONES THAT WERE USED IN THE INCIDENT. THE SYRINGE AND SPINAL NEEDLE IN PACKAGING WERE RANDOMLY SELECTED AND DO NOT REFER TO THE LOT NUMBER." DURING USE LEAKAGE FROM SPINAL NEEDLE HUB. ADDITIONAL INFORMATION: NO PATIENT OR USER WAS HARMED IN THIS INCIDENCE. ADDITIONAL INFORMATION: ACCORDING TO THE CUSTOMER, THERE WAS NO VISIBLE DAMAGE TO THE SYRINGE. IT APPEARED THAT THERE WAS A SMALL CRACK IN THE HUB OF THE SPINAL NEEDLE. UNFORTUNATELY, THE PACKAGING FOR BOTH THE SYRINGE AND THE SPINAL NEEDLE WAS DISCARDED. THEY LOOKED FOR IT IN THE WASTE BUT WERE UNABLE TO FIND IT. THEREFORE, IT IS NOT POSSIBLE TO IDENTIFY THE LOT NUMBER.

Additional Manufacturer Narrative

H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.