BEUDAMED
    FDA Adverse Event Injury Summary report: N

    14F X 28CM ASH SPLIT CATH

    MDR report key: 374894 · Received January 25, 2002

    Report

    Report Number
    2518902-2002-00015
    Event Type
    Injury
    Date Received
    January 25, 2002
    Date of Event
    January 8, 2002
    Report Date
    January 17, 2002
    Manufacturer
    MEDCOMP MEDICAL COMPONENTS, INC.
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENOUS SIDE OF THE CATHETER BECAME DISCONNECTED DURING A HEMODIALYSIS TREATMENT. THE PT LOST A LARGE AMOUNT OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 14F X 28CM ASH SPLIT CATH HEMODIALYSIS CATHETER MPB MEDCOMP MEDICAL COMPONENTS, INC. ASPC28 M139750

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention