BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 2-LUMEN 7 FR X 16 CM

    MDR report key: 1244886 · Received November 25, 2008

    Report

    Report Number
    3006425876-2008-00010
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 25, 2008
    Manufacturer
    ARROW INTL INC
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE SPRING WIRE GUIDE RUPTURED, AND A PORTION REMAINS IN THE BODY OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 7 FR X 16 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL INC ZR8059010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK