WHITACRE SET 27GA 3-1/2IN

Additional Manufacturer Narrative

BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: SPINAL/EPIDURAL NEEDLES AND TRAYS. DEVICE FAILURE: NEEDLE DAMAGED / DEFECTIVE.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

Description of Event or Problem

AFTER A LUMBAR PUNCTURE AND IDENTIFICATION OF THE SPINAL SPACE IN THE MANTRIC'S RETINA THERE WAS A DISLOCATION TO THE SAME INCLUDING THE CANHAR THAT SHOULD BE COUPLED TO THE SYRINGE CONTAINING ANESTHETIC TO BE INSERTED PLACED THE SHARP IN A SAFE ENVIRONMENT TO PREVENT ANYONE FROM PIERCING BUT BEFORE TAKE US A PHOTO SAMPLES IS ATTACHED.

Additional Manufacturer Narrative

(B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A CANNULA IS OBSERVED SEPARATED FROM THE HUB, VERIFYING THE REPORTED INCIDENT. IT CANNOT BE DEFINITIVELY IDENTIFIED FROM THE PHOTO IF IT WAS THE SPINAL NEEDLE OR STYLET THAT SEPARATED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2405031, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. A CANNULA PULL FORCE AND STYLET PULL FORCE TEST IS PERFORMED ON THE RETAINED SAMPLES TO EVALUATE THE FORCE REQUIRED TO SEPARATE THE HUB FROM THE CANNULA OR THE HUB FROM THE STYLET. RESULTS VERIFIED PRODUCT MET REQUIRED SPECIFICATIONS. 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. WITHOUT THE PHYSICAL SAMPLE TO FURTHER EVALUATE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. 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.