BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3851629 · Received April 18, 2014

    Report

    Report Number
    9680794-2014-00094
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PT'S RADIAL ARTERY IN THE OPERATING ROOM. DURING INSERTION, THE PHYSICIAN PASSED THE NEEDLE INTO THE PT'S WRIST AND HIT THE ARTERY WITH THE FIRST PASS. SHE ATTEMPTED TO THREAD THE GUIDE WIRE INTO THE ARTERY. IT WAS ADVANCED ABOUT HALF WAY IN AND THEN SHE FELT RESISTANCE. THE PHYSICIAN ATTEMPTED TO PULL THE GUIDE WIRE BACK AND IT WOULD NOT MOVE. AS A RESULT, THE CATHETER AND WIRE WERE REMOVED AS ONE AND A BEND WAS OBSERVED AT THE END OF THE WIRE NOT ALLOWING IT TO RETRACT. THE PT DEVELOPED A HEMATOMA AT THE SITE BUT AFTER PRESSURE WAS HELD, IT DID NOT GET ANY BIGGER. AS A RESULT, A NEW CATHETER WAS PLACED SUCCESSFULLY. THERE WAS A DELAY IN TREATMENT AND NO PT DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238491 RA CATH SET: 20 GA X 1-1/2" ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC 14F13L0057

    Patients

    Seq Age Sex Outcome Treatment
    1