BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SPINAL NEEDLE

    MDR report key: 20007397 · Received August 20, 2024

    Report

    Report Number
    9610048-2024-00129
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    February 2, 2024
    Report Date
    March 31, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    BSP
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: MIXED PRODUCT/LOTS.

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, SIX (6) PICTURE SAMPLES WERE PROVIDED. THROUGH EXAMINATION OF THE PICTURES, IT WAS VERIFIED THAT THE CUSTOMER RECEIVED MIXED PRODUCT, TWO (2) SHELF CARTONS OF SPINAL NEEDLE 26G LOT 3296599 WERE INSIDE THE SHIPMENT BOX OF SPINAL NEEDLE 27G LOT 3296600. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 408381 AND LOT NUMBER 3296600. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. HOWEVER, IT WAS DISCOVERED THAT THE LOT INVOLVED IN THE REPORTED MIXED PRODUCT WAS RUN THROUGH MANUFACTURING PRIOR TO THE MANUFACTURE OF MATERIAL NUMBER 408381 AND LOT NUMBER 3296600. BASED ON THE INVESTIGATION RESULTS, THE CAUSE HAS BEEN DETERMINED AS POSSIBLE LINE CLEANING FAILURE AS WELL AS A FAILURE IN THE DETECTION SYSTEM. IN RESPONSE TO THIS INCIDENT, AN AWARENESS BULLETIN FOR ALL AFFECTED PACKAGING PERSONNEL WAS INITIATED AND A QUALITY NOTIFICATION WAS OPENED TO ADDRESS THE CORRECTIVE ACTIONS NEEDED TO MITIGATE THIS DEFECT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SPINAL NEEDLE TWO DIFFERENT SIZES FOUND IN A UNIT BOX. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: CS, BELOW IS A QUALITY DEVIATION, I AWAIT YOUR ANALYSIS SO THAT WE CAN PROCEED WITH THE NFD AND DEAL WITH THE CREDIT. A QUALITY DEVIATION WAS IDENTIFIED FOR ITEM: 013469 DESCRIPTION: SPINAL 27GX3 1/2 RAKI NEEDLE CX C/25UN 408381 FROM LOT: 3296600. IN THE SHIPPING BOX WE FOUND (B)(4) UNITS OF ITEM: 013468 DESCRIPTION: SPINAL RAKE NEEDLE 26GX3 1/2 CX C/25UN 408380 FROM LOT: 3296599, WHICH DID NOT ARRIVE AT OUR CD. NF 766627.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372344 BD SPINAL NEEDLE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3296600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown