BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 12 FR X 20 CM

    MDR report key: 1170222 · Received September 11, 2008

    Report

    Report Number
    3006425876-2008-00001
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED, AND HICALIQ AND INOVAN WERE CONTINUOUSLY BEING INFUSED INTO THE PATIENT. AT ABOUT FOUR DAYS LATER, WHILE THE CLINICIAN WAS CHANGING THE POSITION OF THE PATIENT IN BED, THE INJECTION HUB SEPARATED FROM THE EXTENSION LINE. AFTER THE EVENT, THE LINE WAS SECURED WITH CLIPS TO PREVENT THE PATIENT FROM BLEEDING OUT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 12 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC ZF7095367

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INOVAN| HICALIQ