BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX

    MDR report key: 2935587 · Received January 23, 2013

    Report

    Report Number
    MW5028784
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 23, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THE PATIENT'S CESAREAN SECTION, THE PHYSICIAN ATTEMPTED TO PLACE AN EPIDURAL CATHETER. THE END OF THE EPIDURAL CATHETER WAS NOT VISIBLE ON REMOVAL, AND IT WAS DETERMINED THAT THE TIP OF THE CATHETER WAS RETAINED IN THE PATIENT'S LUMBAR FORAMEN. A CT SCAN ON (B)(6) 2012, IDENTIFIED THE RETAINED FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33436 PORTEX 20G EPIDURAL CATHETER WITH STYLET BSO SMITHS MEDICAL ASD, INC. 6947-02 2168223

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR