BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREVI-STF

    MDR report key: 3040607 · Received March 13, 2013

    Report

    Report Number
    1316297-2013-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    PMA / PMN Number
    954584
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EPIMED FOR EVALUATION.

    Description of Event or Problem · 1

    AN EPIMED CATHETER WAS SHEARED BY THE INTRODUCER NEEDLE LEAVING APPROXIMATELY 98 CM INSIDE THE PT. IT WAS SUGGESTED TO THE PHYSICIAN THAT A NEUROSURGEON BE CONSULTED WITH REMOVING THE SHEARED OFF SECTION OF THE CATHETER FROM THE PT. AS A RESULT, THE SHEARED OFF SECTION WAS SUCCESSFULLY REMOVED AND NO ADVERSE AFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106312 BREVI-STF EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. 155-2343 11435192

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other