BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN 3ML SFTY COMBO 23X1

    MDR report key: 7969454 · Received October 16, 2018

    Report

    Report Number
    1017768-2018-00511
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    October 9, 2018
    Report Date
    December 5, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/15/2018. 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 NO. 817654 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. PRIOR TO A LOT¿S 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 INSPECTED FOR FOREIGN MATTER. THE LOT MET THE ACCEPTANCE CRITERIA AND WAS RELEASED. THE DHRS FOR THE SHOP ORDERS UTILIZED IN THE PRODUCTION OF THE SAFETY NEEDLES WERE ALSO REVIEWED. AN AUDIT WAS PULLED FROM ONE (1) OF THE SHOP ORDERS, IDENTIFYING TWO (2) MOLDING RELATED ISSUES THAT DID NOT AFFECT THE NEEDLE. SPECIFICALLY, THERE WAS A MELTED SHEATH CAUSED BY A HOT CORE PIN. THERE WERE NOT ENOUGH DEFICIENCIES FOUND IN THE AUDIT TO REJECT FOR THIS PARTICULAR QUALITY CHARACTERISTIC AND IT PRESENTS NO RISK TO THE PATIENT, SINCE THE SHEATH IS REMOVED FROM THE DEVICE PRIOR TO USE. THIS WAS THE ONLY FINDING. THERE WERE NO NCRS ISSUED AGAINST ANY OF THE SHOP ORDERS. A REVIEW OF THE ENTIRE DHR IDENTIFIED NO MANUFACTURING OR INSPECTION ANOMALIES. A REVIEW OF 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. ADDITIONALLY, A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND REVEALED NO ISSUES. 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. THE EQUIPMENT WAS REVIEWED FOR ISSUES THAT COULD HAVE POTENTIALLY CAUSED THIS ISSUE, BUT NOT WERE IDENTIFIED. THERE WERE NO SAMPLES RETURNED WITH THIS COMPLAINT. THE EXACT NATURE OF THE ALLEGED ISSUE COULD NOT BE DETERMINED. A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. THE 6M ROOT CAUSE ANALYSIS EVALUATED SEVERAL CONTRIBUTING FACTORS AND FOUND ONE (1) POTENTIALLY RELATED ISSUE WITH THE MANUFACTURE OF THIS PRODUCT. MELTED NEEDLE SHEATHS WERE FOUND DURING A SHOP ORDER AUDIT, BUT THERE WERE NOT ENOUGH DEFICIENCIES FOUND TO REJECT THE SHOP ORDER. IT¿S POSSIBLE THE CUSTOMER RECEIVED A NEEDLE WITH A MELTED SHEATH, HOWEVER SINCE A SAMPLE WAS NOT RETURNED, THERE¿S INSUFFICIENT INFORMATION TO DETERMINE A MOST PROBABLE ROOT CAUSE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. THE INFORMATION REVIEWED SHOWED NO SIGNS OF A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS. IF THE CUSTOMER RECEIVED A NEEDLE WITH A MELTED SHEATH, IT PRESENTS NO RISK TO THE PATIENT SINCE THIS ISSUE WOULD NOT IMPAIR THE FUNCTIONALITY OR EFFECTIVENESS OF THE DEVICE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE REPORTED CUSTOMER COMPLAINT IS NOT 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: FOREIGN MATERIAL FOUND ON END OF SYRINGE NEEDLE WHEN NURSE OPENED THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811164 MAGELLAN 3ML SFTY COMBO 23X1 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881833310 817654

    Patients

    Seq Age Sex Outcome Treatment
    1