BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 20 CM

    MDR report key: 3972882 · Received April 28, 2014

    Report

    Report Number
    3006425876-2014-00091
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION IN THE ICU, THE CHIEF NURSE WAS UNABLE TO SUCCESSFULLY INSERT THE SWG/CATHETER RESULTING IN THE KINKING OF THE SWG. A NEW KIT WAS OPENED, HOWEVER, THERE WAS NO REPORTED DEATH OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE. SEE MDR 3006425876-2014-0092 FOR SECOND COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253596 CVC SET: 3-LUMEN 7FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1