BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUN-L-KATH EPIDURAL CATHETER

    MDR report key: 1060865 · Received May 16, 2008

    Report

    Report Number
    1316297-2008-00001
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 16, 2008
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    PMA / PMN Number
    954584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO EPIMED FOR EVAL.

    Description of Event or Problem · 1

    ON 4/17/2008 EPIMED INTERNATIONAL WAS MADE AWARE THAT A PHYSICIAN, DURING A LYSIS PROCEDURE, ENCOUNTERED RESISTANCE WHILE PLACING THE CATHETER. HE WAS ABLE TO REMOVE THE CATHETER AND NEEDLE TOGETHER BUT NOTICED THE DISTAL END OF THE CATHETER HAD SHEARED. HE OBSERVED THAT 3"-4" OF THE CATHETER REMAINED IN THE PT. AFTER CONFERRING WITH ANOTHER PHYSICIAN AND NEUROSURGEON, HE CHOSE TO REMOVE THE REMAINING CATHETER FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUN-L-KATH EPIDURAL CATHETER EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. 155-1520 112-02642

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RK EPIDURAL NEEDLE