BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX CONTINUOUS EPIDURAL TRAY

    MDR report key: 3131029 · Received May 20, 2013

    Report

    Report Number
    2183502-2013-00238
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT STATED DURING AN INJECTION VIA THE DEVICE, THE CONNECTOR BECAME DISCONNECTED. IT WAS REPORTED THAT PT REC'D A DOSE OF PREVENTIVE ANTIBIOTICS. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223506 PORTEX CONTINUOUS EPIDURAL TRAY CAZ - ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention