BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 8.5FR X 20CM

    MDR report key: 2201422 · Received August 3, 2011

    Report

    Report Number
    3006425876-2011-00062
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 THE INTENSIVE CARE UNIT PLACED THE CATHETER INTO THE VENA JUGULARIS OF THE PT. THE PT WAS RECEIVING ANTIBIOTIC, KALIUM, INSULIN, AND HEPARIN. TWO DAYS AFTER INSERTION, THE CLINICIAN DISCOVERED A LEAK IN THE CATHETER BODY JUST BELOW THE JUNCTURE HUB. AS A RESULT, THE CATHETER WAS EXCHANGED SUCCESSFULLY FOR THE PT. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS OAKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 8.5FR X 20CM ARROWG+ARD CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF1014038

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR