BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL STERILE WRAPPER

    MDR report key: 2888731 · Received December 20, 2012

    Report

    Report Number
    MW5028340
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 20, 2012
    Manufacturer
    KIMBERLY CLARK
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATE 1 INCH SLICE/CUT WAS FOUND IN THE WRAPPER OF A BASIN USED IN A SPINAL SURGERY CASE. THE CUT WAS CLEAN, LIKE A KNIFE AND WENT THROUGH BOTH LAYERS OF THE WRAP. THIS WAS THE OUTER WRAPPER AND DRAPED UNDER THE BASIN ON THE RING STAND. CASE WAS UPGRADED TO A LEVEL 2 WOUND RELATED TO THE BREACH IN STERILE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STERILE WRAPPER SURGICAL STERILE WRAPPER KCT KIMBERLY CLARK KC400 LR2206000

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR