BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 2100693 · Received May 18, 2011

    Report

    Report Number
    3006425876-2011-00034
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN REMOVING THE CATHETER IN THE PT'S ROOM WITH THE PT IN SITTING POSITION, RESISTANCE WAS MET RESULTING IN THE CATHETER GETTING SEPARATED APPROX 7CM FROM THE DISTAL TIP. A CT WAS TAKEN AND IT CONFIRMED THAT THE SEPARATED END OF THE CATHETER REMAINED IN THE PT, RESULTING IN SURGERY TO REMOVE IT. THE CATHETER WAS USED FOR A C-SECTION OPERATION. THERE WAS NO DELAY, DEATH, OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC. ZF0123038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention