BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 22011360 · Received May 13, 2025

    Report

    Report Number
    3002682307-2025-00063
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 13, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903031290
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 241109. 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 PICTURES AND TWO (2) NEEDLE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE NEEDLES, THE PRESENCE OF EPOXY DROPS AT THE CANNULA TIPS WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, IT HAS BEEN DETERMINED THAT THE MATERIAL DETECTED ON THE CANNULA IS EPOXY, THE ADHESIVE USED TO JOIN THE METAL CANNULA WITH THE PLASTIC HUB COMPONENT. THIS ISSUE OCCURRED DURING THE ASSEMBLY PROCESS WHEN THE ADHESIVE WAS ADDED TO THE HUB, DUE TO SOME MALFUNCTION IN THE EPOXY DOSAGE MACHINE. 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 EPOXY ON NEEDLE (INVESTIGATION FINDING). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE PAINT ON NEEDLE. WHEN DID THE INCIDENT OCCUR? BEFORE USE. ANESTHESIA DEPARTMENT OCCASIONALLY COMPLAINS ABOUT THE ADHESION OF THE WHITE COLOR, HERE WITH TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879778 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 241109 00382903031290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown