BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 19877576 · Received July 31, 2024

    Report

    Report Number
    3002682307-2024-00153
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 5, 2024
    Report Date
    September 27, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 240411. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, A SHELF CARTON OF ONE HUNDRED (100) PACKAGED NEEDLES WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. TWENTY (20) NEEDLES WERE RANDOMLY SELECTED FOR THOROUGH ANALYSIS. THE NEEDLES WERE USED TO PUNCTURE A LABORATORY VIAL (PLASTIC STOPPER) AND NO DIFFICULTIES WERE IDENTIFIED. AFTER TESTING, THE SAMPLES WERE MICROSCOPICALLY EXAMINED AND NO PARTICLES FROM VIAL STOPPER FRAGMENTATION WERE FOUND, AND ALL NEEDLE BEVELS WERE WELL FORMED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS CANNOT BE DETERMINED. WITH THE PREVENTIVE MEASURES IN PLACE, IT IS UNLIKELY THAT THE CORING EFFECT RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA. IT IS POSSIBLE THAT THE STOPPER CONDITIONS (ASK YOUR SUPPLIER FOR MATERIAL CHANGES AS WELL AS RECOMMENDATIONS OF STORAGE IN CASE HUMIDITY AND/OR TEMPERATURE AFFECTS THE FRAGMENTATION OF THE RUBBER) AND THE HANDLING OF THE PRODUCT HAD A ROLE IN THE REPORTED INCIDENT. AS THIS NEEDLE HAS A BLUNT BEVEL, IT SHOULD PENETRATE THE STOPPER AT A 90-DEGREE ANGLE TO MINIMIZE THE RISK OF CORING. IF THE AFFECTED PHYSICAL SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO PERFORM A THOROUGH ANALYSIS. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    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 · 0

    (B)(6) 2024: - DILUTION WAS DONE WITH AN ANTIBIOTIC, PIPERACILLIN/TAZOBACTAM. - IT WAS NOT ADMINISTERED TO ANY PATIENT BECAUSE THE PIECES OF RUBBER WERE VISUALIZED IN THE VIAL, I HAVE IT SAVED IN CASE YOU WANT TO CHECK IT. - THE REFERENCE IS (B)(4) AND THE BATCH IS 240411, EXPIRY DATE 03/2029.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES NEEDLE CORING THE VIAL RUBBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN THE NEEDLE ENTERS THE VIAL, IT TAKES RESIDUES OF THE MATERIAL FROM THE VIAL CAP, WHICH THEN REMAIN IN THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739884 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown