BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVENT NEEDLE ONLY 25 X 1

    MDR report key: 8047429 · Received November 7, 2018

    Report

    Report Number
    1017768-2018-00516
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 29, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 810062 INDICATED THE PRODUCT WAS RELEASED MEETING ALL QUALITY STANDARDS. ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. IN-PROCESS PROCEDURES ARE ALSO IN PLACE TO PREVENT NONCONFORMING PRODUCT IN THE MANUFACTURING PROCESS. THIS ENSURES COMPONENTS AND FINISHED PRODUCTS MEET ALL QUALITY INSPECTION STANDARDS. THESE CONTROLS INCLUDE, BUT ARE NOT LIMITED TO: MATERIAL VERIFICATION/CERTIFICATION PROCESSES, DIMENSIONAL SPECIFICATIONS, STATISTICAL SAMPLINGS, PERIODIC AUDITS, PROCESS INSPECTIONS, MACHINE MAINTENANCE/OPERATION AND PERSONNEL TRAINING AND CERTIFICATION. SPECIFICALLY, SAMPLES ARE INSPECTED FOR SHIELD STALL/LOCKING FAILURE AND CANNULA FREE LENGTH. DHRS WERE ALSO REVIEWED FOR THE SAFETY NEEDLES ASSEMBLED FOR THIS LOT. PHYSICAL SAMPLES INSPECTED FROM THE SHOP ORDERS FOR ALL INVOLVED LOTS IDENTIFIED NO ISSUES OR NCRS ISSUED AGAINST THE SHOP ORDERS. IN ADDITION, REVIEW FOR NONCONFORMANCE FOUND NO NCRS ISSUED AGAINST THE MOLDED SHIELDS OR CANNULA USED IN PRODUCTION OF THIS PRODUCT. A REVIEW OF THE ENTIRE DHR FOUND NO MANUFACTURING OR INSPECTION ANOMALIES. MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS SHOWED NO ISSUES RELATED TO THE REPORTED CONDITION. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED. THERE WERE NO PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED CONDITION FOR THIS PRODUCT. PROCESS MONITORING DATA WAS REVIEWED FOR THE ASSEMBLY EQUIPMENT AND THERE WERE NO ISSUES RELATED TO THE REPORTED CONDITION. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND REVEALED NO ISSUES. THIS DEVICE IS MANUFACTURED IN A CONTROLLED AND MONITORED ENVIRONMENT AND GOES THROUGH THE FOLLOWING PROCESSES: INJECTION MOLDING, NEEDLE ASSEMBLY AND PACKAGING. THESE PROCESSES ARE HIGHLY AUTOMATED WITH LIMITED HUMAN INTERACTION. THE EQUIPMENT WAS REVIEWED FOR ISSUES THAT COULD HAVE POTENTIALLY CAUSED THIS EVENT, BUT NONE WERE IDENTIFIED. THERE WERE NO SAMPLES RETURNED WITH THIS COMPLAINT, SO THE EXACT NATURE OF THE ISSUE COULD NOT BE DETERMINED. THE 6M ROOT CAUSE ANALYSIS DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURING PROCESS FOR THE NEEDLES THAT WOULD HAVE CAUSED THIS ISSUE. THERE WAS ONE POTENTIAL ROOT CAUSE PERTAINING TO THE USE OF THE DEVICE, BUT THERE¿S INSUFFICIENT INFORMATION TO DETERMINE IF THIS IS THE TRUE ROOT CAUSE. NO PRODUCT/SAMPLE WAS PROVIDED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. THEREFORE, A COMPREHENSIVE INVESTIGATION WAS UNABLE TO BE CONDUCTED. THE INFORMATION REVIEWED SHOWED NO SIGNS OF A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE SAFETY FEATURE FAILED TO REMAIN LOCKED AFTER IT WAS CLICKED INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886200 PREVENT NEEDLE ONLY 25 X 1 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 26559 810062

    Patients

    Seq Age Sex Outcome Treatment
    1