BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN AFFIX

    MDR report key: 8536025 · Received April 19, 2019

    Report

    Report Number
    MW5086029
    Event Type
    Malfunction
    Date Received
    April 19, 2019
    Date of Event
    April 15, 2019
    Report Date
    April 17, 2019
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD.
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN BREAKING THE SKIN AFFIX AMPULE, THE GLASS TUBE INSIDE OF IT PENETRATED THROUGH THE PLASTIC SKIN AFFIX APPLICATOR AND STRUCK THROUGH THE STERILE BLOOD CONTAMINATED GLOVE, PUNCTURING THE STAFF EMPLOYEE'S SKIN ON LEFT INDEX FINGER CAUSING HIM TO BLEED. EMPLOYEE'S BLOOD AND BODY FLUID WAS DIRECTLY EXPOSED TO THE PT'S BLOOD/BODY FLUID. THIS IS A HIGH RISK OF CROSS CONTAMINATION BETWEEN PT AND STAFF. EMPLOYEE TAKEN TO EMPLOYEE HEALTH FOR TREATMENT, AND A NEEDLE STICK BLOOD DRAW PROFILE WAS REQUESTED FROM THE PT. PER PACKET INSERT INSTRUCTIONS, IT INSTRUCTS TO BREAK THE AMPULE BY SQUEEZING IT SHOWING A PICTURE USING YOUR THUMB AND INDEX FINGER. THIS WAS REPORTED TO THE SALES REP FOR MEDLINE. MEDLINE, US. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324919 SKIN AFFIX TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN MPN ADVANCED MEDICAL SOLUTIONS LTD. P00211472

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other