BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 2864443 · Received December 5, 2012

    Report

    Report Number
    9680794-2012-00070
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 5, 2012
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SWG UNRAVELED INSIDE THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED. IT IS UNKNOWN IF THERE WAS A DELAY IN TREATMENT. NO PATIENT COMPLICATIONS OR DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCT DQY ARROW INTERNATIONAL INC. CF2032567

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK