BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHERES-FLOW CENTRAL VENOUS CATHETER

    MDR report key: 272514 · Received April 6, 2000

    Report

    Report Number
    1056436-2000-00066
    Event Type
    Injury
    Date Received
    April 6, 2000
    Date of Event
    March 2, 2000
    Report Date
    March 9, 2000
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 03/09/2000, THE MFR RECEIVED A REPORT VIA A FAX FROM THE FACILITY THAT STATES THE FOLLOWING: PLACED IN INTERVENTIONAL RADIOLOGY 2000. PT CONTAMINATED CATHETER PRIOR TO INSERTION (SOAKED IN BETADINE). PACKED WITH 2000U HEPARIN EACH LUMEN. ON 01/28/2000, UNABLE TO DRAW TIMES THREE "PA" INSTILLED. PACKED WITH 5000U HEPARIN PER LUMEN. ON 02/01/2000, PT HAD TEMPERATURE OF 99.5 CULTURES DRAWN. ON 02/02/2000 TEMPERATURE WAS 100.2-ADMITTED FOR ANTIBIOTIC. COLLECTED 02/05-02/08/2000. HOME ON ANTIBIOTICS. ADMITTED FOR HIGH DOSE CHEMO AND TRANSPLANT ON 02/17/2000. HAD COME INTO CLINIC EVERY 2-3 DAYS FOR HEPARIN CHANGE AND SITE CARE. TEMPERATURE SPIKED ON 03/01/2000, AND CULTURES TAKEN, 03/07/2000, TIP-COAG. NEG. STAPH. NO FURTHER DETAILS WERE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention