BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PI CVC KIT: 3-L 7 FR X 20 CM AGB

    MDR report key: 4173597 · Received August 7, 2014

    Report

    Report Number
    1036844-2014-00338
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 4, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4).

    Description of Event or Problem · 1

    SEE MDR 1036844-2014-00337 FOR THE FIRST EVENT WITH THE SAME PATIENT. IT WAS REPORTED THE SECOND CATHETER WAS BEING PLACED INTO THE PATIENT'S SUBCLAVIAN VEIN IN THE INTENSIVE CARE UNIT. AGAIN, THE WIRE BECAME KINKED DURING INSERTION. THEY DID NOT USE THE RAULERSON SYRINGE. A THIRD KIT WAS OPENED AND THE CLINICIAN STILL EXPERIENCED DIFFICULTY INSERTING THE WIRE. THE WIRE DID NOT KINK AND THEY WERE ABLE TO SUCCESSFULLY PLACE THE CATHETER. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT HARM AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. THE SECOND AND THIRD KITS WERE OPENED FOR NEW SPRING WIRE GUIDES ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463145 PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCT FOZ ARROW INTERNATIONAL INC. 23F14C1151

    Patients

    Seq Age Sex Outcome Treatment
    1