BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1994265 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00026
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 13, 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
    IL, US
    Reporter Occupation
    NURSE

    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 CATHETER WAS PLACED IN THE PT'S RIGHT ARM (BASILIC VEIN) TO ADMINISTER CHEMOTHERAPY DRUGS. THE NURSE DREW LABS, FLUSHED THE CATHETER AND IT "SQUIRTED" OR STARTED LEAKING. THERE WAS NO RESISTANCE ENCOUNTERED. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW CATHETER WAS PLACED IN THE PT'S LEFT ARM. ADD'L INFO RECEIVED ON (B)(6) 2011, FROM THE SALES REP STATED THE CATHETER WAS LEAKING AT THE HUB. THERE WAS A COUPLE OF HOURS DELAY IN TREATMENT. THERE WAS NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT HAS A NEW PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) AND IS RECEIVING THERAPY.

    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 RF0105175

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR