BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHERES-FLOW CENTRAL VENOUS CATHETER KIT

    MDR report key: 395153 · Received May 16, 2002

    Report

    Report Number
    1056436-2002-00063
    Event Type
    Malfunction
    Date Received
    May 16, 2002
    Date of Event
    April 13, 2001
    Report Date
    May 16, 2002
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    MSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 04/2002, THE USER FACILITY'S SPECIAL PROCEDURES MANAGER INFORMED THE MANUFACTURER'S REPRESENTATIVE OF THE FOLLOWING: PHYSICIAN FLUSHED DEVICE PRIOR TO IMPLANT, DEVICE FUNCTIONING AS INTENDED. AFTER IMPLANT FLUSHING ATTEMPTED, PINHOLE LEAK OBSERVED IN ARTERIAL EXTENSION LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHERES-FLOW CENTRAL VENOUS CATHETER KIT CHRONIC CATHETERS MSD HORIZON MEDICAL PRODUCTS, INC. NA SE00356

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other