BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 7079600 · Received December 4, 2017

    Report

    Report Number
    3002682307-2017-00107
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 14, 2017
    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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6). RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 170727. ROOT CAUSE: BASED ON AVAILABLE INFORMATION, WE UNDERSTAND A BROKEN HUB (PLASTIC PART) ISSUE TOOK PLACE. HOWEVER, SINCE WE WERE UNABLE TO DUPLICATE OR CONFIRM YOUR INDICATED FAILURE MODE BECAUSE NO SAMPLE NEITHER PICTURES WERE PROVIDED, AND REVIEW OF DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, A DEFINITIVE ROOT CAUSE WAS POSSIBLE TO DETERMINATE AT THIS TIME. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RECONSTITUTION OF AN INJECTION TREATMENT, THE NEEDLE ON A BD¿ BLUNT FILL NEEDLE BROKE AT ITS BASE AND FELL INTO THE CONTAINER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860574 BD¿ BLUNT FILL NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 170727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other