BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHERES-FLOW CENTRAL VENOUS CATHETER KIT

    MDR report key: 281180 · Received June 8, 2000

    Report

    Report Number
    1056436-2000-00110
    Event Type
    Other
    Date Received
    June 8, 2000
    Date of Event
    March 17, 2000
    Report Date
    May 11, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 05/11/2000, THE DISTRIBUTOR'S BUYER INFORMED THE MANUFACTURER'S (MFR) REPRESENTATIVE OF THE FOLLOWING: WHEN THE DEVICE WAS OPENED IN SURGERY, A HAIR WAS NOTED INSIDE THE STERILE WRAPPING IN THE KIT TRAY. THE SURGERY PERSONNEL CLOSED THE STERILE WRAPPING AND PLACED THE KIT BACK IN THE POUCH AND GAVE THE KIT TO THE DISTRIBUTOR'S SALES REPRESENTATIVE. THE SALES REPRESENTATIVE OPENED THE KIT AND DID NOT SEE THE HAIR IN QUESTION. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE WAS SCHEDULED TO BE RETURNED TO THE MFR. FOR ANALYSIS/EVALUATION.

    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 SE98510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other