BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF-150ML BX50

    MDR report key: 1051491 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00046
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    March 1, 2007
    Report Date
    March 12, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REPORT: ROOT CAUSE IDENTIFIED: ROOT CAUSE HAS NOT BEEN IDENTIFIED. CONCLUSION:. THE LUER LOCK NUT, ONCE IT IS ASSEMBLED SHOULD NOT DETACH FROM THE BARREL; 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

    COVIDIEN REGIONAL OFFICE REPORTS THAT CUSTOMER STATES: BY THE TRANSACTION OF A LAEVOCARDIOGRAPHIE - ADJUSTMENT 14ML/S - 30ML AMOUNT - THE WHOLE "THROW-OVER-RING" OF THE LUER LOCK-CLOSURE WOULD BE BLASTED AFTER A INJECTION-ADJUSTMENT OF APPROXIMATELY 10ML. ALREADY SIX SYRINGES HAD THE SAME DEFECT. IN SOME EXTENT THE WHOLE "MALE" PART OF THE LUER LOCK-CLOSURE WOULD BE DEMOLISHED. NO PERSON INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF-150ML BX50 DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900101 6251361

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK