BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 19777436 · Received July 18, 2024

    Report

    Report Number
    3002682307-2024-00148
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 25, 2024
    Report Date
    August 19, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 240416. 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, THREE (3) UNOPENED NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE NEEDLES WERE USED TO PENETRATE A LABORATORY VIAL AND NO DIFFICULTIES WERE IDENTIFIED. THE NEEDLES WERE THEN MICROSCOPICALLY EXAMINED AND NO PARTICLES FROM VIAL STOPPER FRAGMENTATION WERE OBSERVED AND THE BEVELS WERE WELL-FORMED. AT THIS TIME, A CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE IT IS UNLIKELY THAT THE REPORTED INCIDENT RESULTED FROM POOR OR INSUFFICIENT DE-BURRING OF THE CANNULA COMPONENT. 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 SHORT BEVEL, IT SHOULD PENETRATE THE VIAL STOPPER AT A NINETY-DEGREE ANGLE TO MINIMIZE THE RISK OF CORING. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES; NEEDLE CORES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN THE NEEDLE IS INSERTED INTO THE RUBBER STOPPER OF THE VIAL, THE NEEDLE BREAKS THE RUBBER AND BREAKS OFF PIECES INTO THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033086 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240416 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown