BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1052555 · Received May 22, 2008

    Report

    Report Number
    1036844-2008-00081
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THERE WAS STRONG RESISTANCE WHEN INSERTING THE SPRING WIRE GUIDE (SWG) THROUGH THE ARROW RAULERSON SYRINGE, BUT CONTINUED TO PROCESS. EVENTUALLY, THE CLINICIAN DECIDED TO STOP FORCING THE SWG AND INSTEAD TRIED TO REMOVE IT. DURING REMOVAL THE SWG BROKE, BUT THE CLINICIAN WAS ABLE TO REMOVE ALL OF IT FROM THE PT WITHOUT DIFFICULTY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 7FR X 2 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC CF7036701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention