NEEDLE SPINAL S/SU 25GA 2IN QUINCKE

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.

Description of Event or Problem

MATERIAL # 405078 BATCH # 4094878 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 25 X 2 SPINAL NEEDLE WAS BEING USED FOR A PATIENT'S INJECTION, AND WHEN TRYING TO INJECT MEDICATION THERE WAS RESISTANCE AND IT WAS OCCLUDED. NEEDLE WAS REMOVED AND STYLET WAS PLACED BACK IN TO SEE IF THERE WAS STILL AN OCCLUSION. THE STYLET HELPED WITH THE OCCLUSION AND THEN INJECTION WAS ABLE TO BE FINISHED. THIS IS THE SECOND NEEDLE FROM THIS LOT 4094878 TO HAVE AN OCCLUSION AT THE BEGINNING OF PROCEDURE. DATE OF EVENT: (B)(6)2025 NO HARM TO PATIENT

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&TRAYS. DEVICE FAILURE: NEEDLE CLOGGED/BLOCKED.

Description of Event or Problem

NO ADDITIONAL INFORMATION.