BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 100ML WITH HANDIFIL BX50

    MDR report key: 1051368 · Received May 16, 2008

    Report

    Report Number
    9610849-2008-00021
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Report Date
    August 3, 2005
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    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 BLACK FOREIGN BODY ADHERED TO INNER WALL OF SYRINGE BARREL. FURTHER VISUAL INSPECTION UNDER MICROSCOPE 10X IT WAS UNDETERMINED THE COMPOSITION OF PARTICULATE, INSPECTION YIELDED THAT PARTICULATE WAS NOT PART OF THE ANY MOLDED SUB-ASSEMBLY. THIS CONFIRMED BY FACT THAT NO LOOSE GATE REMNANTS OR FLASHES WERE SEEN ON ANY MOLDED COMPONENT. THERE WAS A COMPLETE REVIEW OF THE OPERATIONAL CONDITIONS OF THE LF MANUFACTURING LINE FROM MARCH 2005 TO MAY 2005 WERE BOTH EQUIPMENTS 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

    REPORTER REPORTS: TWO SYRINGE BARREL WITH BLACK FOREIGN BODY TO BE ATTACHED TO INSIDE OF THEM WERE FOUND. ONE WAS COLLECTED BY US. THE OTHER WAS DISPOSED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYR 100ML WITH HANDIFIL BX50 DISPOSABLE SYRINGE, EMPTY FMF COVIDIEN 302100 4240068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK