BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC KIT 2-LUMEN: 5 FR X 19-5/8 (50 CM)

    MDR report key: 2052027 · Received March 2, 2011

    Report

    Report Number
    1036844-2011-00075
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    LJS
    PMA / PMN Number
    K061289
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 CATHETER WAS BEING PLACED IN THE PT'S UPPER RIGHT ARM. THEY REC'D BLOOD RETURN AND FLUSHED THE CATHETER WITH 10CC THEN STARTED THE CT SCAN WITH WARMED CONTRAST TO BODY TEMPERATURE. THE CT WAS RUNNING AT 2ML PER SECOND WHEN THE TECHNICIAN HEARD A POP AND STOPPED THE PROCEDURE. THEY NOTICED THE CATHETER CRACKED NEAR THE JUNCTURE HUB. AS A RESULT, INTERVENTIONAL RADIOLOGY WAS NOTIFIED AND THEY PERFORMED AN OVER-THE-WIRE EXCHANGE USING AN ANGIODYNAMICS CATHETER. THERE WAS A 7 HOUR DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS FINE. IT WAS NOTED THEY WERE USING A MALLINCKRODT OPI VANTAGE MACHINE. ADDITIONAL INFORMATION REC'D ON (B)(4) 2011 BY THE SALES REP CONFIRMED THAT THEY WAITED BETWEEN EACH STEP TO ANALYZE THE SITUATION AND THEN FOR THE NEW PLACEMENT AND TO GET TIP VERIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC KIT 2-LUMEN: 5 FR X 19-5/8 (50 CM) PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTERNATIONAL INC RF0117156

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ANGIODYNAMICS CATHETER