BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX CONTINUOUS EPIDURAL TRAY

    MDR report key: 3082925 · Received April 22, 2013

    Report

    Report Number
    2183502-2013-00168
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH PT FOR TREATMENT OF CHRONIC PAIN (TIME IN USE NOT PROVIDED). ACCORDING TO THE REPORT THE CATHETER BROKE AND APPROXIMATELY 9 CM OF THE CATHETER REMAINED IN PT EPIDURAL SPACE. ACCORDING TO REPORT THE PT MET WITH CONSULTING NEUROSURGEON WHO RECOMMENDED NO ACTION UNLESS CERTAIN SYMPTOMS OCCURRED. PT WAS DISCHARGED FROM HOSPITAL CARE WITH NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171532 PORTEX CONTINUOUS EPIDURAL TRAY CAZ - ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC NA 2330284

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention