BD SPINAL/EPIDURAL NEEDLES & TRAYS

Description of Event or Problem

IT WAS REPORTED THAT BD SPECIAL NEEDLE WEISS BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BROKEN DURING USE IN SURGERY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025. IS THERE ANY IMPACT ON PATIENTS? IF SO, PLEASE EXPLAIN IN DETAIL. NO. COULD YOU CONFIRM THE DATE OF THE EVENT? (B)(6) 2025.

Additional Manufacturer Narrative

H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED FINAL MATERIAL NUMBER 408356 AND LOT NUMBER 4312073. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE NEEDLE BARREL WAS OBSERVED DEFECTIVE. A MOLDING DEFECT WAS OBSERVED IN THE PRODUCT CAUSED BY THE MANUFACTURING MOLDING PROCESS. MANUFACTURING AND PACKAGING PERSONNEL HAVE BEEN ALERTED OF THIS INCIDENT FOR FURTHER AWARENESS ON THE PRODUCTION FLOOR. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.