BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN

    MDR report key: 7440745 · Received April 18, 2018

    Report

    Report Number
    1017768-2018-00036
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    March 20, 2018
    Report Date
    September 4, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUBMISSION DATE: 09/04/2018. LOT NUMBERS: 324521X, 33680, 420970, 429377X, 432883X, 533806, 601846, 612341, 615859, 618086, 705898, 700988, 714353, 717322, 724245, 725817, 728291, 801048. AN INVESTIGATION WAS PERFORMED FOR THE REPORTED CUSTOMER COMPLAINT: ¿THE CUSTOMER REPORTS THAT PRIOR TO USE, THEY FOUND PLASTIC PARTICLES ATTACHED TO THE NEEDLES.¿ MULTIPLE LOT NUMBERS ARE INVOLVED IN THIS CUSTOMER COMPLAINT. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND APPROVED BY QUALITY PRIOR TO RELEASE OF PRODUCT. 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 FOREIGN MATTER AND MOLDING FLASH. ALL LOT NUMBERS MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. FOR ANY DISCREPANCY IDENTIFIED DURING FINAL REVIEW OF A DHR, AN ACTION MUST BE TAKEN TO REMEDIATE THE ISSUE PRIOR TO RELEASE. PRODUCT REPORTED FOR THIS COMPLAINT WERE IDENTIFIED AS: 8881850310 23GA X 1IN MAGELLAN SAFETY NDL / 8881850215 22GA X 1.5IN MAGELLAN SAFETY NDL / 8881850210 22GA X 1IN MAGELLAN SAFETY NDL / 8881850515 25GA X 1½IN MAGELLAN SAFETY NDL / 8881850115 21GA X 1.5IN MAGELLAN SAFETY NDL FIVE (5) LARGE BOXES TOTAL WERE RETURNED FOR EVALUATION. ALL BOXES WERE IDENTIFIED AS HAVING THE SAME QA REFERENCE NUMBER AND RELATED TO THE REPORTED CUSTOMER ISSUE OF PLASTIC PARTICLES ATTACHED TO THE NEEDLES. THE BOXES CONTAINED NEEDLES (THOUSANDS) IN DIFFERENT PLASTIC BAGS AND PAPER BAGS. PER THE CUSTOMER, NONE OF THE NEEDLES WERE UTILIZED ON PATIENTS AND CUSTOMER ONLY OPENED AND INSPECTED FOR QUALITY ASSURANCE PURPOSES. FOR THIS INVESTIGATION, 1,829 (UNOPENED) SAMPLES WERE RECEIVED FOR EIGHTEEN (18) DIFFERENT LOT NUMBERS. LOT NUMBERS WERE IDENTIFIED AS: 324521X, 33680, 420970, 429377X, 432883X, 533806, 601846, 612341, 615859, 618086, 705898, 700988, 714353, 717322, 724245, 725817, 728291, AND 801048. SAMPLES WERE PULLED FROM THIS POPULATION AND VISUALLY INSPECTED FOR STRING FLASH. THE PRESENCE OF STRING FLASH WAS OBSERVED. THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS 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. THE GATE STRINGS ARE NOT ENDEMIC TO ANY PARTICULAR MANUFACTURING LOT. IT IS LIKELY THAT THE GATE STRINGS WOULD BE DETECTED PRIOR TO USE AND WOULD RESULT IN THE DEVICE BEING DISCARDED PRIOR TO USE. CUSTOMER RESPONSE IS CONSISTENT WITH THIS EXPECTATION. THE ABILITY TO DETECT THIS ISSUE ASSISTS IN THE DECREASING LIKELIHOOD OF A POTENTIAL ADVERSE EVENT. AN ISSUE IMPACT ASSESSMENT (AS KNOWN AS A HEALTH HAZARD EVALUATION OR HEALTH HAZARD ASSESSMENT) WAS CONDUCTED FOR MAGELLAN GATE STRINGS. THE ASSESSMENT DISCUSSES A POTENTIAL HAZARD SCENARIO WHERE THE PLASTIC FIBERS ARE INJECTED INTO A PATIENT AND ASSESSES THE RISKS ASSOCIATED WITH SUCH AN EVENT. THE OVERALL RISK SCORE WAS ¿LOW¿ FOR THAT ASSESSMENT. BASED ON THE LOW RISK ASSOCIATED WITH THE ISSUE, NO ADDITIONAL CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE REPORTED CUSTOMER COMPLAINT IS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS DUE TO FLASH. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT PRIOR TO USE, THEY FOUND PLASTIC PARTICLES ATTACHED TO THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284566 MAGELLAN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881850115 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1