BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-WITH HF-150ML (LINDEN LUER)

    MDR report key: 1051372 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00011
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    August 3, 2004
    Report Date
    August 3, 2004
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS/CORRECTIVE ACTIONS: ACCORDING TO RESULTS OBTAINED IN THE INVESTIGATION, THE DEFECT REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. SINCE THE FAILURE MODE WAS NOT DUPLICATED, NO CORRECTIVE ACTIONS ARE DERIVED OF THIS INVESTIGATION. IT WILL BE HELPFUL IF THE SAMPLE THAT FAILED COULD BE RETURNED FOR EVALUATION BECAUSE ALL THE TESTING PERFORMED WAS MADE UNDER PRODUCT THAT WAS NOT USED YET AND THAT MET ALL THE QUALITY REQUIREMENTS. THIS CUSTOMER COMPLAINT WILL BE REOPENED IF DEFECTIVE SAMPLE IS RECEIVED. THIS DEFECT REPORTED IS CONSIDERED AN ISOLATED CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT PRODUCT SPILLS OUT OF (LEAKS) AT CONNECTOR. THIS HAS OCCURRED TWICE. IN ONE INSTANCE, THE TUBING CAME OFF AND CONTRAST SPRAYED INTO TECHNOLOGIST'S EYE. CUSTOMER IS NOT SURE WHICH TUBING IS USED (NAMIC POSSIBLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-WITH HF-150ML (LINDEN LUER) DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900103 4156123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK