NEEDLE SPINAL S/SU 22GA 1-1/2IN QUINCKE

Description of Event or Problem

NO ADDITIONAL INFORMATION.

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 (B)(6) 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON (B)(6) 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON (B)(6) 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR (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 HUB DAMAGED/DEFECTIVE.

Additional Manufacturer Narrative

SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BD DEVICES ARE DESIGNED TO BE MOLDED COMPONENTS COMPATIBLE WITH ISO DIMENSIONS. THEREFORE, IS RECOMMENDED TO USE SYRINGES COMPATIBLE WITH ISO STANDARDS. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Description of Event or Problem

MATERIAL# 405161 BATCH# 3059930. VERBATIM UNABLE TO ADMINISTER INTRATHECAL CHEMOTHERAPY. ALL, DAY 24 CONSOLIDATION LUMBAR PUNCTURE WITH IT HC/MTX UNDER DEEP SEDATION, UNABLE TO SAFELY CONNECT CHEMOTHERAPY SYRINGE TO LP NEEDLE, CHEMOTHERAPY SYRINGE COMPROMISED OUTSIDE OF STERILE FIELD. THE PLASTIC HUB OF 22G, 1.5 INCH LP NEEDLE SLIGHTLY MISSHAPED AT SEAM. REF (B)(4), LOT 3059930.

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.