BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMENA-SYR-WITH HF-150ML (LINDEN LUER)

    MDR report key: 1051367 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00020
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    August 2, 2005
    Manufacturer
    COVIDIEN
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED SAMPLE DID CONFIRM CUSTOMER REPORTED FAILURE MODE, IN THE FORM OF A YELLOW TYPE SOLID OBJECT ADHERED TO INSIDE OF SYRINGE BARREL. FURTHER VISUAL INSPECTION UNDER MICROSCOPE 10X REVEALED FOREIGN OBJECT TO BE SOLID MASS YELLOW IN COLORATION. THERE ARE NO MATERIALS USED IN THE ASSEMBLY PROCESS WHICH COULD ORIGINATE THE TYPE OF OBJECT SEEN BY CUSTOMER. THERE WAS A COMPLETE REVIEW OF THE OPERATIONAL CONDITIONS OF THE LF MANUFACTURING LINE FROM MARCH 2005 TO MAY 2005 WERE BOTH EQUIPMENT AND PERSONNEL CLEANING AND GOWNING PRACTICES, IDENTIFYING THE POTENTIAL SOURCES OF FOREIGN OBJECTS WHICH WERE ADDRESSED AS LISTED BELOW. CONCLUSIONS/CORRECTIVE ACTIONS: THE NEXT ACTIONS WERE TAKEN TO PREVENT THE FOREIGN OBJECTS IN PRODUCT OR ITS PACKAGE. REINFORCE THE 6S PROGRAM IN MANUFACTURING AREA, WHICH CONSISTS ON DAILY CLEANING ROUTINES BY OUR MANUFACTURING PERSONNEL DURING SHIFT TRANSITIONS. MATERIAL HANDLING PRACTICES WERE CHANGED TO PREVENT THE ADHESION OF FOREIGN PARTICLES TO COMPONENTS SUCH AS THE ROLL STOCK WHICH IS THE RAW MATERIAL FOR THE SYRINGE TRAY. STICKY MATS WERE INSTALLED IN THE ENTRANCE DOOR OF THE MANUFACTURING AREA TO COLLECT THE DUST FORM THE PERSONNEL SHOES BEFORE THEY GET INTO THE ASSEMBLY AREA. GOWNING PRACTICES WERE REVIEWED WITH ALL LF ASSEMBLY LINE PERSONNEL TO REINFORCE ITS CORRECT APPLICATION WHICH INCLUDE THE ADEQUATE USE AND REPLACEMENT OF HEAD COVERS.

    Description of Event or Problem · 1

    (B) (4) REPORTS: A FOREIGN OBJECT ON A YELLOW LIQUID STATE WAS FOUND INSIDE THE SYRINGE BARREL. WE WANT TO KNOW WHAT THIS FOREIGN BODY IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMENA-SYR-WITH HF-150ML (LINDEN LUER) DISPOSABLE SYRINGE, EMPTY DXT COVIDIEN 900103 4177101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK