BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 1950411 · Received December 14, 2010

    Report

    Report Number
    9610849-2010-00018
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 17, 2010
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE IDENTIFIED: NO. SAMPLE NOT PROVIDED FOR EVAL. CONCLUSIONS: DEVICE HISTORY RECORD FOR FINAL PRODUCT COULD NOT BE REVIEWED SINCE LOT NUMBER WAS NOT PROVIDED. DEFECT REPORTED WAS NOT CONFIRMED SINCE SAMPLE WAS NOT RECEIVED FOR EVAL. CORRECTION ACTIONS: THIS COMPLAINT WILL BE FILED FOR QA TRENDS.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE, THE SYRINGES LUER LOCK NUT IS NOT ATTACHING CORRECTLY AND THE ARGON HIGH PRESSURE TUBING IS DETACHING DURING INJECTIONS. NO SPECIFIC DATES, TIMES OR TYPES OF PROCEDURES REPORTED. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 EMPTY, DISPOSABLE SYRINGE DXT COVIDIEN 150ML ILLUMENA SYR NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK