BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOJECT NEEDLE

    MDR report key: 6405852 · Received March 15, 2017

    Report

    Report Number
    3005581270-2017-00003
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 22, 2017
    Report Date
    February 23, 2017
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    IKT
    PMA / PMN Number
    K002992
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD WILL BE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. CUSTOMER HAS ALSO BEEN CONTACTED TO ADVISE ON THE PATIENT HEALTH STATUS AND THE OUTCOME OF THE SURGERY.

    Description of Event or Problem · 1

    TRANSLATION OF CUSTOMER REPORT: THE NEEDLE HAD TWISTED SEVERAL TIMES BEFORE BECAUSE THE PATIENT WAS MOVING, THE BRAIN INJURY THAT HE PRESENTS CAUSING A LACK OF CONTROL OF THE REFLEXES, HIS MUSCLES ARE DEEP AND POWERFUL BECAUSE IT MAKES (B)(6). THE FACT THAT THE NEEDLE TWISTS DID NOT WORRY ME BECAUSE IT IS VERY THIN (37 MMX0.41 MM, 27 G) AND THIS HAS ALREADY HAPPENED TO ME WITHOUT CONSEQUENCE. THIS TIME THE NEEDLE BROKE WHEN IT WAS INSERTED INTO ITS SUPPORT AND WHEN I PULLED OUT THE PRESSURE ON THE MUSCLE, IT WAS BURIED IN THE MUSCLE, I COULD NOT REMOVE IT, IT WILL BE REMOVED AT THE OPERATING ROOM OF THE CLINIC OF (B)(6) BY DR. (B)(6) ON MONDAY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188199 BOJECT NEEDLE DISPOSABLE HYPODERMIC NEEDLE IKT ALPINE BIOMED APS 9013S0442 N-2016-06-009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other