BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 1881105 · Received October 1, 2010

    Report

    Report Number
    3006425876-2010-00070
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE INTENSIVE CARE UNIT, THE NURSE NOTICED THAT A PORTION OF THE DRESSING WAS WET AND FOUND A LEAK FROM THE CATHETER WAS THE CAUSE. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. AFTER REMOVING THE CATHETER, THE NURSE FOUND A SMALL CUT APPROXIMATELY 10 CM FROM THE SNAPLOCK ADAPTOR WHICH CAUSED THE LEAK. HOW LONG THE CATHETER WAS INDWELLED OR WHEN IT WAS INSERTED INTO THE PT IS UNK. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC ZF0022925

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK