BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA CATH SET: 20 GA X 1-1/2"

    MDR report key: 4922715 · Received July 17, 2015

    Report

    Report Number
    9680794-2015-00098
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 7, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED BECAUSE NO SAMPLE WAS RETURNED FOR ANALYSIS AND A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. HOWEVER, THE CUSTOMER REPORTED RETRACTING THE NEEDLE WITH THE GUIDE WIRE THROUGH THE NEEDLE BEVEL. THIS ACTION DOES NOT FOLLOW THE GUIDELINES IN THE IFU AND RESULTED IN THE DAMAGE GUIDE WIRE. THEREFORE, IT APPEARS THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RESPIRATORY THERAPIST WAS ATTEMPTING TO PLACE AN ARTERIAL CATHETER IN THE PATIENT'S RIGHT RADIAL. WHEN HE ATTEMPTED TO PULL THE NEEDLE BACK, THE GUIDE WIRE IN THE CATHETER BEGAN TO UNRAVEL. IT APPEARED THE WIRE WAS COMING OUT OF THE NEEDLE AND PART OF IT WAS UNRAVELED ABOVE THE NEEDLE. EVERYTHING WAS REMOVED FROM THE PATIENT INTACT. AS A RESULT, ANOTHER CATHETER WAS THEN PLACED INTO THE PATIENT'S LEFT RADIAL ARTERY SUCCESSFULLY. IT IS NOT KNOWN IF THERE WAS A DELAY IN TREATMENT AND THERE WAS NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466412 RA CATH SET: 20 GA X 1-1/2" ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC. 14F14L0336

    Patients

    Seq Age Sex Outcome Treatment
    1