BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARROW

    MDR report key: 766966 · Received October 3, 2006

    Report

    Report Number
    MW1040575
    Event Type
    Other
    Date Received
    October 3, 2006
    Manufacturer
    ARROW INTERNATIONAL, INC
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS IS NOT A SPECIFIC PT EVENT, BUT RATHER A SAFETY ISSUE. THE ARROW EPIDRUAL TRAYS HAVE DECREASED THE AMOUNT OF ANTISEPTIC SOLUTION IN THEIR PACKAGING ATTRIBUTING THIS TO "IMPROVE POUCH INTEGRITY." HOWEVER, THE SPINAL TRAYS HAVE THE SAME TYPE OF POUCH INCLUDED, 1 (ONE) OZ OF ANTISEPTIC SOLUTION. THE AMOUNT OF BETADINE IS NOT EVEN SUFFICIENT TO SOAK THE THREE PREP SPONGES INCLUDED IN THE KIT (ONLY 3/4 OZ IS INCLUDED). INADEQUATE PREP SOLUTION CAN POTENTIALLY CAUSE AN INFECTION (EPIDURAL ABSCESS, MENINGITIS, PARALYSIS, OR DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW EPIDURAL CATHETERIZATION KIT CAZ ARROW INTERNATIONAL, INC AK05503-L RF6056821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other NH 03431.| BUPIVACAINE #3716-20. PORTEX, INC, KEENE,| PORTEX SPINAL 22 GUAGE, QUICKIE WITH