BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20831373 · Received December 3, 2024

    Report

    Report Number
    3002682307-2024-00245
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 14, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    50382903046275
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304627 AND LOT NUMBER 4003568. 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) PICTURE SAMPLES AND FOUR (4) PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, THREE (3) NEEDLES SHOWED EXCESS EPOXY, THE ADHESIVE USED TO JOIN THE CANNULA AND HUB COMPONENTS. REGARDING THE EPOXY DEFECT, THIS ISSUE RESULTED DURING THE ASSEMBLY PROCESS WHEN THE ADHESIVE IS ADDED TO THE HUB, PROBABLY DUE TO A TEMPORARY STOPPAGE IN THE PROCESS. AS A CONSEQUENCE, A HIGHER QUANTITY OF EPOXY WAS ADDED TO THE HUB RESULTING IN THIS COSMETIC ISSUE. DURING THE PRODUCTION PROCESS, VISUAL INSPECTIONS ARE ROUTINELY PERFORMED TO CHECK FOR DEFECTS, INCLUDING SPILLED EPOXY. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. 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. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. STREET ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES- NEEDLE HAS FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE SENDING YOU THE OFFICIAL COMPLAINT NO. (B)(4) FOR THE MATERIAL NO. 304627 - NEEDLE HYPODERMIC 23G 25MM BLUE (2300086-00). I WOULD LIKE TO INFORM YOU THAT DURING OUR PROCESS WE HAVE FOUND DAMAGED NEEDLE AND WHITE SPOTS OF GLUE ON THE NEEDLES. WHITE SPOTS LOOKS LIKE TOO MUCH GLUE. DEFECT: DAMAGED NEEDLE; SPOTS OF GLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209883 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 4003568 50382903046275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown