BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-CATH

    MDR report key: 284775 · Received June 24, 2000

    Report

    Report Number
    284775
    Event Type
    Injury
    Date Received
    June 24, 2000
    Date of Event
    April 12, 2000
    Report Date
    June 24, 2000
    Manufacturer
    V-CATH
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEAK NOTED IN PICC LINE AT HOME BY MOM. APPROX LCM AND HUB OF CATHETER REMAINING OUTSIDE BODY. CARDIAC CATHETERIZATION PERFORMED TO REMOVE RETAINED PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC DQO V-CATH 360-45 1107

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention