BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA CATH SET: 22 GA X 1-3/8-

    MDR report key: 2243874 · Received August 24, 2011

    Report

    Report Number
    9680794-2011-00058
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM DURING REMOVAL OF THE CATHETER THE ANESTHESIST INSERTED THE CATHETER VIA LEFT RADIAL ARTERY. AFTER THE INSERTION, SEEING THAT THE CATHETER WAS NOT IN PLACE BECAUSE OF SOME RESISTANCE INSIDE THE ARTERY, THE ANESTHESIST DECIDED TO PULL ON THE NEEDLE AND PUSH BACK A COUPLE OF TIMES WITH NO SUCCESS. BY PULLING ON THE CATHETER AND FEELING SOME RESISTANCE (BECAUSE THE PT HAD THROMBOSIS IN THE ARTERY) IS WHEN THE CATHETER CUT ABOUT HALF WAY. AS A RESULT, THE NEEDLE AND CATHETER WERE REMOVED. A NEW KIT WAS OPENED AND USED WITH SUCCESS. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. IT IS UNK IF THERE WAS A DELAY OR INTERRUPTION IN THERAPY. NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. THE PT OUTCOME IS A SMALL PORTION OF THE CATHETER WAS LEFT IN THE ARTERY, BUT WITH NO POSSIBLE COMPLICATIONS FOR HIM. THE ANESTHESIST ALLEGES THAT THE CATHETER KINKED AT THE END OF THE NEEDLE FROM PULLING AND PUSHING BACK THE NEEDLE WHICH MADE A HOLE IN THE CATHETER. THE ANESTHESIST STATES "THAT NO COMPLICATIONS HAPPENED BECAUSE THE PT ALREADY HAD AN ARTERY WITH THROMBOSIS". ALSO STATED THAT "THE LITTLE PIECE OF CATHETER WILL NOT DO ANY HARM TO THE PT" AND FEELS THAT "IT IS A TECHNICAL ERROR FROM HIM AND NOT A PROBLEM FROM THE PRODUCT ITSELF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA CATH SET: 22 GA X 1-3/8- RADIAL ARTERY PRODUCTS DQX ARROW INTERNATIONAL INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR