BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 30GA 1/2IN

    MDR report key: 9008488 · Received September 12, 2019

    Report

    Report Number
    3002682307-2019-00498
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 304000 LOT 180930 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. RESEARCH HAS FOUND NO ABNORMALITIES OR ISSUES IN ASSEMBLED NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE NEEDLE BROKE WITH A BD NEEDLE 30GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DURING AN IVT SESSION, AT THE TIME OF THE INJECTION OF THE PRODUCT, THE DOCTOR NOTICED THAT THE NEEDLE WAS BROKEN, THEREFORE IMPOSSIBLE TO INJECT THE PRODUCT. THE PRODUCT WAS THROWN AWAY AND THE PATIENT WAS CALLED BACK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE NEEDLE BROKE WITH A BD NEEDLE 30GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING AN IVT SESSION, AT THE TIME OF THE INJECTION OF THE PRODUCT, THE DOCTOR NOTICED THAT THE NEEDLE WAS BROKEN, THEREFORE IMPOSSIBLE TO INJECT THE PRODUCT. THE PRODUCT WAS THROWN AWAY AND THE PATIENT WAS CALLED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799654 BD NEEDLE 30GA 1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 180930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other