BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETRIZATION KIT

    MDR report key: 2052035 · Received March 2, 2011

    Report

    Report Number
    1036844-2011-00068
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EPIDURAL CATHETER SEPARATED. ADDITIONAL INFORMATION REC'D ON (B)(6) 2011 FROM HOSPITAL RISK MANAGEMENT STATED, THE CATHETER WAS USED FOR A SUCCESSFUL BLOCK ON A FEMALE PT IN LABOR AND DELIVERY. DURING REMOVAL, THE NURSE PULLED WITH THE NORMAL AMOUNT OF TENSION AND FELT SLIGHT RESISTANCE. AT WHICH TIME, SHE HAD THE PT LEAN FORWARD AND SHE AGAIN PULLED ON THE CATHETER. THE CATHETER WAS REMOVED HOWEVER, THE TIP WAS MISSING. THE PT HAD A LUMBAR CT WHICH SHOWED THE TIP AND POSSIBLY A SMALL PIECE OF THE WIRE WAS RETAINED. THE PT UNDERWENT A NEURO CONSULT AND HAS SINCE BEEN RELEASED FROM THE HOSPITAL. THE PT IS SEEKING A SECOND OPINION. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETRIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC RF0076553

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN