BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 1051406 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00023
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    January 25, 2006
    Report Date
    January 25, 2006
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT: HISTORY RECORD: DEVICE HISTORY RECORD DOES NOT HAVE EVIDENCE OF ANY ABNORMAL CONDITIONS WITHIN THE MANUFACTURING PROCESS. CONCLUSIONS: NO EVALUATION COULD BE PERFORMED DUE TO NO SAMPLE WAS RECEIVED YET. CORRECTIVE ACTIONS: NO CORRECTIVE ACTIONS INITIATED. IF SAMPLE IS RECEIVED, EVALUATION FOR THIS COMPLAINT INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE. DURING ANGIOGRAPHIC PROCEDURE USING A 4FR COOK CATHETER AND NAMIC HIGH PRESSURE TUBING, WHEN THE INJECTION STARTED, THE TUBING BLEW OFF THE TIP OF THE 900101 SYRINGE. CUSTOMER SET RISE TIME ON THE INJECTOR FOR 0.3 WITH A RATE OF 10ML FOR VOLUME OF 20ML. TUBING BLEW OFF SYRINGE TIP THREE TIMES, THE CUSTOMER THEN SET THE RISE TIME FOR 0.8 AND THE INJECTION PROCEEDED NORMALLY. CUSTOMER QUESTIONS THE LUER LOK THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 POWER INJECTOR SYSTEM DXT COVIDIEN ILLUMENA 5343538

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK