BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE GENERAL PACK

    MDR report key: 5390156 · Received January 26, 2016

    Report

    Report Number
    5390156
    Event Type
    Malfunction
    Date Received
    January 26, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 25, 2016
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN HAS CONCERNS THAT THE GAUZE FROM A GENERAL SURGERY PACK IS FLAKING AND SHEDDING. THE GAUZE WAS DISINTEGRATING WITH PATIENT FLUID. MANUFACTURER RESPONSE FOR GAUZE, (B)(6) GENERAL PACK (PER SITE REPORTER): THANK YOU FOR TAKING THE TIME TO INFORM US OF THE RECENT ISSUE YOU HAD WITH YOUR ACCOUNT CONCERNING THE DYNJ33655B (B)(6) GENERAL PACK. MEDLINE TAKES EVERY COMPLAINT WE RECEIVE SERIOUSLY AND INVESTIGATES IT TO THE BEST OF OUR ABILITY. WE UNDERSTAND THE ISSUE YOUR ACCOUNT EXPERIENCED TO BE GAUZE FLAKING DURING USE. MEDLINE UNDERSTANDS THE CRITICAL NATURE ASSOCIATED WITH LINTING ISSUES WITH THE ITEMS WE SUPPLY IN OUR PACKS. A QUERY WAS RUN AND THIS IS THE FIRST COMPLAINT FILED BY THIS ACCOUNT FOR THIS PACK FOR THIS ISSUE. THE MONTHLY USAGE FOR COMPONENT (B)(4) GAUZE 4X4 16PLY XR 10/BANDED AT OUR PRODUCTION FACILITIES IS APPROXIMATELY (B)(4) PER MONTH. AN ITEM OF COMPONENT (B)(4) WAS RECEIVED AS SAMPLE. THE SAMPLE WAS EVALUATED BY SHAKING THE GAUZE WHILE STILL FOLDED WHICH PRODUCED LINT. THERE WAS AN EXCESS AMOUNT OF LINT OBSERVED THAT SUPERSEDED THE INHERENT LINT FOR COTTON MATERIALS. THERE WERE SMALL LINT PARTICLES TO A LOOSE STRING WHICH WAS SLIGHTLY LONGER THAN AN INCH. THE LINT OBSERVED IS UNACCEPTABLE. THE ROOT CAUSE IS CONSIDERED A COMPONENT MANUFACTURING FACILITY ISSUE. THE SAMPLE IS BEING FORWARDED TO OUR QA SPECIALIST TO SEND TO THE COMPONENT MANUFACTURER FOR THEIR REVIEW. THERE HAS BEEN AN IMPLEMENTATION TO THE CUTTING OF THE GAUZE WHICH HAS BEEN REDUCED LINTING SIGNIFICANTLY FOR THE COMPONENT (B)(4). NO FURTHER INVESTIGATION IS NEEDED AT THIS TIME. DIVISION WILL CONTINUE TO MONITOR FOR TRENDING PURPOSES. THE COMPLAINT WILL BE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48813 STERILE GENERAL PACK GENERAL SURGERY TRAY (KIT) LRO MEDLINE INDUSTRIES, INC. 15WB7126

    Patients

    Seq Age Sex Outcome Treatment
    1