BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUN-L-XL

    MDR report key: 114050 · Received August 15, 1997

    Report

    Report Number
    1316297-1997-00005
    Event Type
    Other
    Date Received
    August 15, 1997
    Date of Event
    July 30, 1997
    Report Date
    August 11, 1997
    Manufacturer
    EPIMED INTL., INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR WAS ATTEMPTING TO REMOVE TUN-L-XL FROM PT WHEN CATHETER CAUGHT ON NEEDLE AND SHEARED. APPROX. 6 MM OF THE CATHETER'S DISTAL TIP REMAINS IN THE PT. DECISION HAS NOT BEEN MADE YET TO ATTEMPT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUN-L-XL EPIDURAL CATHETER BSO EPIMED INTL., INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other R.K. EPIDURAL NEEDLE