BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL NEEDLE HOLDER

    MDR report key: 8807582 · Received July 18, 2019

    Report

    Report Number
    MW5088239
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 12, 2019
    Report Date
    July 16, 2019
    Manufacturer
    KNY - SCHEERER CORP.
    Product Code
    GDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN CLEANING INSTRUMENTS THAT HAD JUST BEEN USED IN A SURGICAL CASE, A LION JAW INSERT SEPARATED AND FELL OFF A NEEDLE HOLDER. THE PIECE THAT FELL OFF IS SMALL; 1.2 CM LONG X 0.2CM WIDE. THIS COULD'VE FALLEN INTO THE SURGICAL WOUND UNNOTICED. I CONSIDER THIS A NEAR-MISS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596694 SURGICAL NEEDLE HOLDER GUIDE, NEEDLE, SURGICAL GDF KNY - SCHEERER CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1