BD WHITACRE PENCIL POINT SPINAL NEEDLE WITH INTRODUCER 25G 4.06IN

Additional Manufacturer Narrative

(B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: IT WAS REPORTED THE NEEDLE BROKE DURING USE. ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE NEEDLE IS OBSERVED TO BE BROKEN INTO TWO PIECES, VERIFYING THE REPORTED CONCERN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2404036 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS OBSERVATION. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON ANY OF THE NEEDLES. PRODUCT UNDERGOES VISUAL INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS ACCORDING TO PROCEDURE, VERIFYING THERE ARE NO DEFECTS OR DAMAGE ON THE PRODUCT. LOT RELEASE TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED. IT IS POSSIBLE THE NEEDLE BROKE DUE TO A SPONTANEOUS MOVEMENT OF THE PATIENT OR IF THE NEEDLE HIT A BONE, ALTHOUGH THIS CANNOT BE VERIFIED FOR THIS INCIDENT. BASED ON THE AVAILABLE INFORMATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

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: DURING THE OPERATING SESSION FOR SURGERY IN THE EPIDURAL ANESTHESIA PROCEDURE PHASE WITH THE BD WHITACRE NEEDLE 25 GA 0.50X103MM REF 405112 LOT 2404036 EXPIRY 03/2029, THE NEEDLE BROKE IN HALF AND A PART REMAINED IN THE SITE. WAS THE DEVICE USED IN/ON THE PATIENT WHEN THE PROBLEM OCCURRED? YES HAS THE PATIENT OR USER BEEN HARMED? IF YES, PLEASE PROVIDE A BRIEF EXPLANATION. NO, THE PATIENT DID NOT SUFFER ANY DAMAGE. THE NEEDLE BROKE IN HALF AND PART REMAINED IN THE SITE DID THE PATIENT NEED FURTHER SURGERY TO REMOVE THE BROKEN NEEDLE? NO HAVE THEY MANAGED TO COMPLETE THE ORIGINAL PROCEDURE? YES COMPLETED.