BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KUMAR CLAMP

    MDR report key: 5924236 · Received September 2, 2016

    Report

    Report Number
    5924236
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    August 5, 2016
    Report Date
    August 10, 2016
    Manufacturer
    NASHVILLE SURGICAL INSTRUMENTS
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    KUMAR CLAMP INSTRUMENT NEEDED TO BE CLEANED FOR AN IMMEDIATE TO FOLLOW CASE; THE INSTRUMENT WAS SENT DOWN TO THE STERILE PROCESSING DEPARTMENT WHERE IT WAS WASHED AND BROUGHT BACK TO THE OR TO BE FLASH STERILIZED. UPON INSERTING KUMAR CLAMP INTO PATIENT, THE KUMAR CATHETER FROM THE PREVIOUS PATIENT WAS FOUND TO HAVE BEEN LEFT INSIDE THE KUMAR CLAMP; ALTHOUGH THERE IS A NEEDLE TIP, THE CURRENT PATIENT WAS NOT BELIEVED TO HAVE BEEN PENETRATED BY OLD KUMAR CATHETER. CLAMP AND THE OLD CATHETER WERE REMOVED FROM THE STERILE FIELD. THE KUMAR CATHETER APPEARS TO HAVE HAD A KINK IN IT AND BROKE AT THAT LOCATION WHEN BEING REMOVED FROM THE KUMAR CLAMP AND WAS LODGED INSIDE THE KUMAR CLAMP WHICH WAS NOT CLEARED WHEN CLEANING. THE DEVICE WAS NOT CLEANED PER PROTOCOL, ONLY FLUSHING WAS DONE, NO BRUSHING WAS DONE DUE TO THE QUICK TURNAROUND TO USE FOR THE NEXT CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576584 KUMAR CLAMP CATHETER, CHOLANGIOGRAPHY GBZ NASHVILLE SURGICAL INSTRUMENTS KC-002

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other KUMAR CLAMP KC 200, PT UNDER GENERAL ANESTHESIA.