BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150 ML BX50

    MDR report key: 1051395 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00033
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    January 18, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE IDENTIFIED: ROOT CAUSE HAS NOT BEEN IDENTIFIED. CONCLUSIONS: THE LUER LOCK NUT, ONCE IT IS ASSEMBLED SHOULD NOT DETACH FROM THE BARREL; THE SYRINGE WAS DESIGNED TO KEEP THE LUER NUT IN POSITION DURING THE FUNCTIONAL TEST. CORRECTIVE ACTIONS: CAPA WAS INITIATED TO ADDRESS THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING CARDIAC CATH PROCEDURES, WHEN THE INJECTION IS STARTED, THE LUER LOCK POPS OFF THE SYRINGE TIP. COMMON PROTOCOL IS 10ML/SEC FOR 24ML VOLUME OR 3ML/SEC FOR 6ML VOLUME, WITH 650 - 750 PSI. SYRINGE CONNECTED TO NAMIC HIGH PRESSURE TUBING, CONNECTED TO BOSTON SCIENTIFIC 5FR, 145CM ANGLED PIGTAIL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150 ML BX50 DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900101 6202420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK