SPINAL NEEDLE 27GA 3.50 IN

Additional Manufacturer Narrative

PR 13672061 FOLLOW UP MDR FOR DEVICE EVALUATION: IT WAS REPORTED THAT THE NEEDLE LEAKED DURING USE. ONE VIDEO WAS PROVIDED TO OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL EVALUATION, A LEAKAGE WAS OBSERVED BETWEEN THE SYRINGE AND SPINAL NEEDLE. IT WAS NOTED THAT THE SYRINGE USED IN THE VIDEO IS NOT A BD-MANUFACTURED PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2409028 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS OBSERVATION. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON OR NEAR THE LUER CONNECTION. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE NEEDLE TO A SYRINGE. LIQUID WAS ABLE TO PASS FROM THE SYRINGE THROUGH THE NEEDLE AND NO LEAKAGE WAS OBSERVED. PRODUCT IS VISUALLY AND FUNCTIONALLY TESTED THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. TESTING RESULTS FOR LOT 2409028 VERIFIED PRODUCT MET ALL REQUIRED LIMITS. BASED ON THE AVAILABLE INFORMATION AND WITHOUT THE PHYSICAL SAMPLES, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

INITIAL REPORTER FACILITY NAME: (B)(6). INITIAL MDR, IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

EVENT DETAILS: WHILE PUSHING THE SYRINGE IN, THE MEDICINE LEAKED OUT FROM THE SPINAL NEEDLE HEAD JOINT. IN LOT.2409028, THIS PROBLEM HAS BEEN ENCOUNTERED TWICE ALREADY.