BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 2241177 · Received August 17, 2011

    Report

    Report Number
    2242445-2011-00108
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    CAZ
    PMA / PMN Number
    884552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE PT'S ROOM A DAY AFTER THE CATHETER WAS PLACED. A LEAK WAS FOUND ON THE CATHETER NEAR THE SNAPLOCK. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE SUCCESSFULLY. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY NOTED. NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT OUTCOME IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC MF1040053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK