BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC LL SYRINGE P-LK O/P

    MDR report key: 5942934 · Received September 12, 2016

    Report

    Report Number
    1017768-2016-00069
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 09/12/2016. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. SEVEN SAMPLES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS CONDUCTED UNDER MAGNIFICATION AND IDENTIFIED CONTAMINATION WITH ONE OUT OF THE SEVEN SAMPLES. A SMALL FIBER OF WHAT APPEARED TO BE POLYPROPYLENE WAS STUCK IN THE LOCATION BETWEEN THE TWO WIPER SEALS OF THE PLUNGER TIP. ADDITIONALLY, A PHOTOGRAPH OF A SAMPLE WAS INCLUDED. THE PHOTOGRAPH SHOWED AN OPENED SYRINGE WITH THE PLUNGER DRAWN BACK TO ABOUT THE 2ML GRADUATION LINE. THE SYRINGE CONTAINED A SMALL WHITE STRING-LIKE FIBER, IN ADDITION TO A SMALL AMOUNT OF CLEAR SOLUTION. THE MOST LIKELY ROOT CAUSES WERE RELATED TO THE DEFICIENCIES IN THE CLEANING PROCESS AND ENVIRONMENTAL CONTAMINATION OF THE RUBBER TIPS WHILE CONVEYING IN THE RUBBER TIP TRACKS. PRIOR TO A LOTS RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES ARE VISUALLY INSPECTED FOR PARTICULATE IN THE FLUID PATHWAY. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. A CHANGE ORDER WAS INITIATED TO CREATE STANDARD WORK DOCUMENTATION FOR THE DAILY CLEANING ACTIVITIES IN THE SOFTPACK AND SYRINGE AREAS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 REQUESTING SAMPLE RETURN STATUS. THE REPRESENTATIVE REPORTS SYRINGES FOUND WITH A VERY FINE FIBRE, WHICH APPEARS TO ALSO BE PLASTIC AND WHICH IS IN THE SAME REGION, DIRECT PRODUCT CONTACT AND VERY LIKELY TO EXIT THE SYRINGE UPON APPLICATION OF THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595908 3CC LL SYRINGE P-LK O/P SYRINGE FMI COVIDIEN 8881513934 614100

    Patients

    Seq Age Sex Outcome Treatment
    1