BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHERES-FLOW CENTRAL VENOUS CATHETER KIT

    MDR report key: 252680 · Received December 3, 1999

    Report

    Report Number
    1056436-1999-00202
    Event Type
    Other
    Date Received
    December 3, 1999
    Date of Event
    October 5, 1999
    Report Date
    November 5, 1999
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    1056436-09/01/99-001R
    Report Source
    Manufacturer report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    ON 11/05/1999, THE MFR RECEIVED MEDWATCH REPORT #3600160000-1999-0005 FROM THE FACILITY THAT STATES THE FOLLOWING: THE DEVICE WAS PLACED IN THE PT. PRODUCT RECALLED THROUGH LETTER FROM THE MFR(REF. VOLUNTARY PRODUCT REMOVAL #1056436-09/01/1999-001-R) THIS INFO WAS NOT PROVIDED TO THE HOSP TO PULL THE PRODUCTS. THEREFORE, THE PT HAD THE CATHETER INSERTED PRIOR TO REMOVING THE PRODUCT FROM THE SHELVES. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHERES-FLOW CENTRAL VENOUS CATHETER KIT Implant CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA SE98281

    Patients

    Seq Age Sex Outcome Treatment
    1 Other