BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 16 CM

    MDR report key: 1021254 · Received March 28, 2008

    Report

    Report Number
    1036844-2008-00050
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 BY THE CLINICIAN, THAT THE CATHETER WAS INSERTED SUCCESSFULLY INTO A MALE PATIENT SUFFERING FROM EMPHYSEMA. THE PATIENT WAS SENT FOR A CHEST X-RAY AND 1 CC OF AIR WAS NOTICED IN THE PATIENT'S PULMONARY SPACE. AS A RESULT, THE CATHETER WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. 2008 UPDATE: FOLLOW UP INFORMATION STATED A CT SCAN WAS PERFORMED WHICH INDICATED THE RIGHT AND LEFT INTERNAL JUGULAR AND PULMONARY SPACE SHOWED AIR WAS PRESENT. IMAGES WILL NOT BE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 16 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK