BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 112 S-PLK SP

    MDR report key: 5529931 · Received March 28, 2016

    Report

    Report Number
    1424643-2016-00001
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 22, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER(S) CONFIRMED THAT THE PRODUCT WAS PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS AND RELEASED ACCORDING TO ESTABLISHED PROCEDURES. THE UNIT IN QUESTION WAS RECEIVED FOR EVALUATION. CONTAMINANT WAS VISIBLE INSIDE OF THE SYRINGE. HOWEVER, UPON ACTUATING THE PLUNGER, IT WAS NOTED THAT THE DEBRIS/CONTAMINANT IS GREASE ON THE PLUNGER RIB AND NOT WITHIN THE FLUID PATHWAY OF THE SYRINGE BARREL. THE METHOD OF ROOT CAUSE ANALYSIS THAT WAS IMPLEMENTED IN THIS INVESTIGATION WAS TO CONDUCT A FISH BONE DIAGRAM THAT ADDRESSED THE COMPLAINT. ROOT CAUSE FOR GREASE ON THE SYRINGE PLUNGER IS THE COMPONENTS COMING INTO CONTACT WITH MACHINE PARTS EXHIBITING OIL/GREASE DURING THE EJECTION PROCESS. WHEN PLUNGER COMPONENTS ARE RELEASED FROM THE PLUNGER LINE MOLD, PARTS WERE OBSERVED TO BE VULNERABLE TO COMING INTO CONTACT WITH THE BOTTOM TIE BARS OF THE MACHINE PRESS. OIL OR GREASE RESIDUE FROM THE TIE BARS MAY THUS POTENTIALLY ADHERE ONTO THE PLUNGERS AS THEY EJECT AND FALL ONTO THE CONVEYOR TO CONTINUE TOWARDS THE ASSEMBLY PROCESS. BASED ON THE EXISTING CONTROLS, THE INTERNAL REJECT PROCESS AND THE COMPLAINT HISTORY REVIEW, ADDITIONAL CORRECTION OR CONTAINMENT ACTIVITIES ARE NOT WARRANTED AT THIS TIME. PRODUCT IS ROUTINELY EXAMINED TO ENSURE IT MEETS ACCEPTABLE QUALITY LEVELS (AQL), AND A LOT CANNOT BE RELEASED UNLESS IT PASSES VISUAL AND FUNCTIONAL TESTING REQUIREMENTS. SLEEVES WERE ADDED TO THE UNCOVERED TIE BAR COVERS OF MACHINE PRESSES AS APPLICABLE THROUGHOUT THE SYRINGE FOCUS FACTORY. THIS PREVENTS DIRECT CONTACT BETWEEN EJECTED MOLDED COMPONENTS AND MACHINE PARTS IN THEIR EJECTION TRAJECTORY THAT MAY RESULT IN CONTAMINANT SUCH AS OIL OR GREASE COMING ONTO THE FINISHED GOOD. AS FURTHER CORRECTIVE ACTION, CLEANING OF THESE TIE BAR COVERS WAS ADDED TO THE WEEKLY CLEANING SCHEDULE AS WELL AS THE CLEANING LOG, AND STANDARD WORK FOR CLEANING THE MOLDING PRESSES WAS CREATED. BASED ON THE INFORMATION AVAILABLE AND THE INVESTIGATION FINDINGS, A CAPA DECISION TOOL WAS EXECUTED DUE TO THE INITIAL HIGH RISK DESIGNATION OF THE COMPLAINT. A CAPA WAS NOT DEEMED NECESSARY AS PREVIOUS ACTION HAS BEEN IMPLEMENTED AS CORRECTIVE ACTION FOR THIS FAILURE MODE. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER STATES DEBRIS/CONTAMINATE WAS INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185254 SYR 112 S-PLK SP SYRINGE FMI COVIDIEN 8881112083 15H12963X

    Patients

    Seq Age Sex Outcome Treatment
    1