BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 20844559 · Received December 4, 2024

    Report

    Report Number
    3002682307-2024-00246
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 14, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903032624
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 240609. 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, TWO (2) PICTURE SAMPLES AND TWO (2) PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, ONE (1) NEEDLE DISPLAYED EPOXY (THE ADHESIVE USED TO JOIN THE CANNULA AND HUB COMPONENTS) ALONG THE CANNULA SURFACE. THIS ISSUE RESULTED DURING THE ASSEMBLY PROCESS, WHEN THE ADHESIVE IS ADDED TO THE HUB, DUE TO A TEMPORARY STOPPAGE IN THE PROCESS OR MALFUNCTION IN THE EPOXY DOSAGE MACHINE. AS A CONSEQUENCE, A HIGHER QUANTITY OF EPOXY WAS ADDED AND FELL ONTO THE NEXT CANNULA, RESULTING IN THE OBSERVED ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES HAS FOREIGN MATTER ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WHEN THE PACKAGING IS OPENED, THERE IS A WHITE DEPOSIT ON THE BODY OF THE CANULA.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227545 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 240609 00382903032624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown