BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX CONTINUOUS EPIDURAL TRAY

    MDR report key: 2030343 · Received March 21, 2011

    Report

    Report Number
    2183502-2011-00094
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING REMOVAL FROM USE, THE CATHETER BROKE AND A PORTION REMAINED IN PT. PT WAS GIVEN CT, MRI AND ULTRASOUND BUT THE CATHETER PORTION REMAINING COULD NOT BE SEEN TO ALLOW FOR REMOVAL. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX CONTINUOUS EPIDURAL TRAY CAZ - ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC. NA 1780850

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK