BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4222775 · Received August 6, 2014

    Report

    Report Number
    1036844-2014-00336
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 5, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S INTERNAL JUGULAR IN THE EMERGENCY ROOM. DURING INSERTION THE PHYSICIAN NOTICED RESISTANCE WHEN THREADING THE SPRING WIRE GUIDE THROUGH THE NEEDLE. THE NEEDLE WAS THEN REMOVED AND THE DILATOR WAS INSERTED OVER THE SPRING WIRE GUIDE. AGAIN, THEY PHYSICIAN NOTICED RESISTANCE, BUT WAS ABLE TO THREAD THE DILATOR. AT WHICH TIME, THE SPRING WIRE GUIDE WAS REMOVED FROM THE DILATOR AND THE WIRE WAS FOUND UNRAVELED. EVERYTHING WAS REMOVED FROM THE PATIENT INTACT. A NEW KIT WAS USED SUCCESSFULLY FOR THE PATIENT. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460547 PI CVC KIT: 3-L 7 FR X 20 CM AGB ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 23F13L0280

    Patients

    Seq Age Sex Outcome Treatment
    1