BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 1051380 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00034
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    October 30, 2006
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION. CUSTOMER HAS NOT PROVIDED PRODUCT OR PRODUCT LOT NUMBER FOR INVESTIGATION. IF THE FUTURE, INFORMATION IS REC'D, THEN THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATION PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO SALES REPRESENTATIVE AT THE TCT MEETING THAT THEY WERE EXPERIENCING LUER LOCK NUTS AND CONNECTION TUBING BLOWING OFF THE SYRINGE DURING INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900101 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK