BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAPE IN CUSTOM SURGICAL PACK

    MDR report key: 5676325 · Received May 24, 2016

    Report

    Report Number
    1423395-2016-00038
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    March 29, 2016
    Report Date
    May 24, 2016
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT SOLUTION WAS POOLING IN THE MACHINE UNDER THE DRAPE DURING AN AORTIC ANEURYSM REPAIR/AORTIC VALVE REPLACEMENT. THE MACHINE AND DRAPE WERE REMOVED AND REPLACED. THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THE ANESTHESIOLOGIST CHOSE TO REDOSE THE PATIENT WITH AN ANTIBIOTIC POST-OP PER FACILITY PROTOCOL. THE SAMPLE WAS RETURNED AND EVALUATED. WE CONFIRMED A CRESCENT SHAPED INDENTATION AND A HOLE IN THE PLASTIC DRAPE. THE DRAPE IS LEFT INSIDE OF THE STERILE VENDOR PACKAGING AND IS PIGGYBACKED TO THE CUSTOM SURGICAL PACK. THIS DEVICE IS A COMPONENT IN A CUSTOM SURGICAL PACK AND IS MANUFACTURED BY (B)(4). (B)(4) HAS BEEN NOTIFIED OF THIS INCIDENT. AS THE MANUFACTURER OF THE DEVICE, (B)(4) WILL CONDUCT AN INVESTIGATION AND MAKE THE DETERMINATION IF ANY CORRECTIVE ACTION IS INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOLUTION WAS POOLING IN THE MACHINE UNDER THE DRAPE DURING AN AORTIC ANEURYSM REPAIR/AORTIC VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331660 DRAPE IN CUSTOM SURGICAL PACK LRO MICROTEK MEDICAL, INC. 15VB9470

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other