BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-W/HF- 150ML BX50

    MDR report key: 1051410 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00048
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    March 20, 2007
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG REPORT: ROOT CAUSE IDENTIFIED: ROOT CAUSE HAS NOT BEEN IDENTIFIED. CONCLUSIONS: THE LUER NUT ONCE 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 (B) (4)WAS INITIATED TO ADDRESS THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING PROCEDURE, THE LUER LOCK NUT DETACHED FROM THE SYRINGE TIP UNDER PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-W/HF- 150ML BX50 DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900101 6223331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK