BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX FX

    MDR report key: 6188567 · Received December 20, 2016

    Report

    Report Number
    6188567
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 13, 2016
    Report Date
    December 5, 2016
    Manufacturer
    B.BRAUN MEDICAL, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST CALLED TO LABOR AND DELIVERY FOR THE PLACEMENT OF AN EPIDURAL CATHETER. AFTER THREADING THE EPIDURAL CATHETER INTO THE PATIENT, THE ANESTHESIOLOGIST WAS UNABLE TO ADMINISTER ANY MEDICINE, THE CATHETER LUMEN AND DISTAL PORTS WERE NOT PATENT. THE EPIDURAL CATHETER WAS REMOVED, AND THE MD PROVIDER OPENED A SECOND EPIDURAL KIT (WITH PRESUMABLY THE SAME LOT #), AND DISCOVERED THE SECOND CATHETER HAD THE SAME DEFECT. THE MD PROVIDER ACCESSED A THIRD KIT WITH PRESUMABLY A DIFFERENT LOT # FROM THE ANESTHESIA SUPPLIES CABINET IN LABOR AND DELIVERY, AND THIS TIME WAS ABLE TO RE-ACCESS THE PATIENT'S EPIDURAL SPACE AND ADMINISTERED EPIDURAL MEDICINE WITH GOOD EFFECT AND WITHOUT FURTHER ISSUES. ALL EPIDURAL CATHETER KITS WITH THE SAME LOT # AS THE DEFECTIVE NON PATENT KITS, WERE REMOVED AND SEQUESTERED PENDING MANUFACTURER NOTIFICATION. MANUFACTURER RESPONSE FOR EPIDURAL CATHETER, PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY WITH PERIFIX 1 GA X 3-1/2 IN (9CM) TUOHY EPIDURAL NEEDLE WINGED AND SPRINGWOUND EPIDURAL CATHETER 19 GA CLOSED TIP (PER SITE REPORTER): NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841525 PERIFIX FX ANESTHESIA CONDUCTION KIT CAZ B.BRAUN MEDICAL, INC. CE17TKFCS 0061519932

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR NO| NO OTHER THERAPIES