BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 2 0CM

    MDR report key: 1881104 · Received October 1, 2010

    Report

    Report Number
    9680794-2010-00068
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    January 20, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE SPRING WIRE GUIDE (SWG) WAS BEING REMOVED, IT WAS OBSERVED THAT THE COIL WAS COMPLETELY DAMAGED. AS A RESULT, A NEW SET WAS OPENED AND SUCCESSFULLY PLACED IN THE PT. ADDITIONAL INFO WAS RECEIVED ON 09/21/2010 STATING THAT THE SWG DID UNRAVEL; HOWEVER, BUT STILL INTACT. THE TIP ON THE END OF THE SWG CAN BE OBSERVED. THERE WERE NO PT COMPLICATIONS OR DELAY IN THERAPY REPORTED. NO INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7FR X 2 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC CF9082918

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK