BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDHICON MONOCRYL 3-0

    MDR report key: 4833886 · Received May 21, 2015

    Report

    Report Number
    4833886
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 15, 2015
    Manufacturer
    ETHICON
    Product Code
    MOF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MONOCRYL 3-0 WAS BEING USED BY PHYSICIAN TO STITCH PERITONEAL TISSUE. WHEN SHE PUT THE NEEDLE INTO THE TISSUE AND REMOVED THE NEEDLE HOLDER TO GRAB THE OTHER END OF THE NEEDLE, THE SUTURE BROKE OFF RIGHT WHERE IT CONNECTED TO THE NEEDLE. THE MD WAS NOT CERTAIN WHETHER IT WAS STILL IN THE PT OR IF IT HAD FLIPPED OFF THE FIELD SOMEWHERE. THE PT HAD TO WAIT IN THE OPERATING ROOM UNTIL AN X-RAY WAS DONE TO DETERMINE IF THE NEEDLE WAS IN THE ABDOMEN. THE NEEDLE WAS IDENTIFIED IN THE ABDOMEN, BUT UNSURE OF THE DEPTH, SO ANOTHER X-RAY WAS TAKEN FROM THE SIDE TO DETERMINE WHERE THE NEEDLE WAS LOCATED. THE MD TRIED TO USE A MAGNET TO FIND THE NEEDLE TO NO AVAIL. THE PHYSICIAN HAD TO MANUALLY FEEL THE SUBCUTANEOUS TISSUE TO FIND THE NEEDLE, LUCKILY SHE DID NOT GET STUCK. THE LOT NUMBER IS EAM348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333864 EDHICON MONOCRYL 3-0 NEEDLE MOF ETHICON EAM348

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other