BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PACK

    MDR report key: 3962555 · Received June 27, 2014

    Report

    Report Number
    1920664-2014-00102
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE STABLE CHAMBER COLLECTION CASSETTE ASSEMBLY WAS RETURNED IN A PLASTIC BAG. THE ORIGINAL PACKAGING WAS NOT RETURNED. THE PART NUMBER AND LOT NUMBER CANNOT BE VERIFIED OR DETERMINED. THERE WAS FLUID IN THE TUBING AND COLLECTION CASSETTE. THERE WAS DEBRIS VISIBLE IN THE SOCK OF THE IN-LINE FILTER. THE ASSEMBLY LOOKS USED. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE COLLECTION CASSETTE WAS CAPTURED, RECOGNIZED AND PASSED THE SELF VACUUM TEST. THE ASSEMBLY PRIMED, IRRIGATED AND ASPIRATED AS INTENDED. THE ASSEMBLY WAS NOT CLOGGED. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) STATING: "STABLE CHAMBER CLOGGED, NO ASPIRATION. NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376152 MICRO INCISION VACUUM PACK HQC BAUSCH & LOMB, INC. BL5113 V2520

    Patients

    Seq Age Sex Outcome Treatment
    1