BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY NEEDLE 25 G X 1"

    MDR report key: 8256922 · Received January 17, 2019

    Report

    Report Number
    1017768-2019-00559
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 12, 2018
    Report Date
    February 20, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 821923 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. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES ARE INSPECTED FOR FOREIGN MATTER AND CONTAMINATION. THE LOT MET THE ACCEPTANCE CRITERIA AND WAS RELEASED. 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 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. PROCESS MONITORING DATA IS NOT COLLECTED FOR THE MOLDING MACHINE. THERE WERE NO PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED CONDITION FOR THIS PRODUCT. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND REVEALED NO ISSUES. NO PRODUCT/SAMPLE WAS PROVIDED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. THEREFORE, A COMPREHENSIVE INVESTIGATION WAS UNABLE TO BE CONDUCTED. HOWEVER, THE ISSUE DESCRIPTION PROVIDED WITH THIS COMPLAINT WAS SIMILAR TO OTHER COMPLAINTS FOR MOLDING FLASH (STRING FLASH) RECEIVED FOR THE SAME PRODUCT AROUND THE SAME TIMEFRAME, SO IT¿S PRESUMED THIS ISSUE IS RELATED. THE EXACT ROOT CAUSE OF THE MOLDING FLASH COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. THE MOST LIKELY ROOT CAUSE WAS DUE TO FLASH, WHICH IS STRINGY PLASTIC MATERIAL ATTACHED AT THE MOLDED PART'S GATE (THE ENTRANCE TO THE MOLD CAVITY) FORMING WHEN MELTED PLASTIC RESIN REMAINS AT THE INJECTION GATE AS THE TWO MOLD HALVES SEPARATE. AN ISSUE IMPACT ASSESSMENT (AS KNOWN AS A HEALTH HAZARD EVALUATION OR HEALTH HAZARD ASSESSMENT) WAS CONDUCTED FOR MAGELLAN GATE STRINGS. THE BIOCOMPATIBILITY TESTING REPORT FOR THE MAGELLAN SAFETY NEEDLES REVEALED THAT THE PRODUCT DEMONSTRATED NO EVIDENCE OF CYTOTOXICITY, THE MATERIAL HAS NO EVIDENCE OF POTENTIAL SENSITIZATION, NO EVIDENCE OF HEMOLYSIS AND NO EVIDENCE OF ACUTE SYSTEMIC TOXICITY. THE BIOCOMPATIBILITY TESTING REPORT CONFIRMS THE POTENTIAL HARM IS LOW RISK. THE OVERALL RISK SCORE WAS ¿LOW¿ FOR ISSUE IMPACT ASSESSMENT. BASED ON THE LOW RISK ASSOCIATED WITH THE ISSUE, NO ADDITIONAL CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE MOLDING FLASH. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE MEDICAL ASSISTANT WAS GETTING READY TO GIVE A VACCINE TO PATIENT. WHEN SHE REMOVED THE HUB FROM THE NEEDLE SHE NOTICED FIBERS ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49974 SAFETY NEEDLE 25 G X 1" NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881850510 821923

    Patients

    Seq Age Sex Outcome Treatment
    1