BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHERES-FLOW CENTRAL VENOUS CATHETER KIT

    MDR report key: 272404 · Received April 5, 2000

    Report

    Report Number
    1056436-2000-00062
    Event Type
    Malfunction
    Date Received
    April 5, 2000
    Report Date
    March 3, 2000
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 03/07/2000, THE FACILITY'S BUYER INFORMED THE MFR'S REPRESENTATIVE OF THE FOLLOWING: THE CATHETER BROKE OFF. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHERES-FLOW CENTRAL VENOUS CATHETER KIT CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other