BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 9086604 · Received September 19, 2019

    Report

    Report Number
    9086604
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    August 21, 2019
    Report Date
    August 28, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    LRO
    UDI-DI
    00191072046130
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    QUESTIONABLE STERILITY ASSURANCE ISSUE; WHAT APPEARED TO BE A DEAD BUG WAS FOUND IN THE SELF CONTAINED BASIN/WRAP WITHIN IN THE STERILE SUPPLY PACK. BUG WAS LOST DURING EXAMINATION PROCESS, THEREFORE CAN NOT PROVIDE FOR EXAMINATION. ISSUE IDENTIFIED & RECTIFIED; NO PATIENT EXPOSURE. INTRA-OP STAFF REPORTS THE FOLLOWING. WHILE SETTING UP FOR THE CASE AFTER THE PATIENT WAS ALREADY IN THE OPERATING ROOM, A QUESTIONABLE BUG WAS FOUND IN THE BLUE BASIN IN THE ORTHO MAJOR PACK. THE BLUE BASIN WAS WRAPPED SEPARATELY FROM THE REST OF THE PACK. AFTER THE SCRUB TECH DISCOVERED THE QUESTIONABLE BUG, SHE DID NOT TOUCH ANYTHING ELSE ON THE STERILE FIELD. SHE ALSO HAD NOT REMOVED ANYTHING FROM THE WRAPPED BASIN. SCRUB TECH REMOVED GLOVES AND TRANSFERRED INSTRUMENTS TO A SEPARATE STERILE FIELD. SURGEON NOTIFIED. A NEW PACK WAS OPENED. QUALITY WAS INFORMED AND PACK WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881073 ACS STERILE SURGICAL SUPPLY PACK LRO AMERICAN CONTRACT SYSTEMS, INC. CDHI12D 846191 00191072046130

    Patients

    Seq Age Sex Outcome Treatment
    1