BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONDERANFERTIGUNG HKL

    MDR report key: 744592 · Received July 1, 2005

    Report

    Report Number
    1526863-2005-00035
    Event Type
    Malfunction
    Date Received
    July 1, 2005
    Date of Event
    June 1, 2005
    Report Date
    June 6, 2005
    Manufacturer
    MEDEX, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT SAMPLES WOULD BE RETURNED FOR EVALUATION HOWEVER THEY HAVE NOT BEEN RECEIVED. WITHOUT THE RETURNED UNIT THE EXACT CAUSE OF THE ISSUE CAN NOT BE DETERMINED. NO PRODUCT FROM THE LOT NUMBERS WERE REMAINING IN STOCK FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. MEDEX IS UNABLE TO CONFIRM OR DETERMINE THE ACTUAL CAUSE OF THIS INCIDENT WITHOUT BENEFIT OF RETURNED PRODUCT.

    Description of Event or Problem · 1

    THE ROTATING ADAPTER WAS SEPARATING FROM THE MANIFOLD. NO PATIENT INJURY OR TREATMENT ASSOCIATED WTIH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONDERANFERTIGUNG HKL FLUID ADMINISTRATION SET FMF MEDEX, INC. NA 35C04K44RV09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN