BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RACZ TUN-L-XL

    MDR report key: 160794 · Received March 30, 1998

    Report

    Report Number
    1316297-1998-00002
    Event Type
    Malfunction
    Date Received
    March 30, 1998
    Date of Event
    February 27, 1998
    Report Date
    March 30, 1998
    Manufacturer
    EPIMED INT.
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE CONCLUSION OF AN EPIDURAL BLOCK, DR. ATTEMPTED TO WITHDRAW THE CATHETER. THE DISTAL TIP CAUGHT AND SEVERED, LEAVING APPROXIMATELY .050 INCHES OF THE DISTAL END IN THE PATIENT. CATHETER PIECE LEFT IN THE BODY CONSTRUCTED OF 100% 304V SURGICAL GRADE STAINLESS STEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RACZ TUN-L-XL EPIDURAL CATHETER BSO EPIMED INT. 155-2540 101097

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other