BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVENT NEEDLE ONLY 18 X 1 1/2

    MDR report key: 8236697 · Received January 10, 2019

    Report

    Report Number
    1017768-2019-00557
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    November 30, 2018
    Report Date
    January 25, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 810057 INDICATES PRODUCT AND SPECIFICATION REQUIREMENTS WERE MET WITH NO NON-CONFORMING PRODUCT IDENTIFIED RELATING TO THIS CUSTOMER REPORT. A LOT CANNOT BE RELEASED UNLESS IT PASSES ALL QUALITY AND CONFORMANCE REQUIREMENTS. 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 INCLUSIONS AND FOREIGN MATTER. 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. PROCESS MONITORING DATA IS NOT COLLECTED FOR THE MOLDING MACHINE. THERE WERE NO PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED EVENT. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND REVEALED NO ISSUES. A REVIEW OF THE ENTIRE DHR FOUND NO INSPECTION OR MANUFACTURING ANOMALIES. THE SHOP ORDERS FOR THE SAFETY NEEDLES ASSEMBLED FOR THIS LOT WERE ALSO REVIEWED. THERE WERE NO NCRS ISSUED AGAINST ANY OF THE SHOP ORDERS AND NO ISSUES REPORTED PERTAINING TO PRODUCT VISUAL/PHYSICAL INSPECTIONS. THERE WERE ALSO NO NCRS ISSUED AGAINST THE SHOP ORDERS OF THE MOLDED SAFETY SHIELDS UTILIZED IN PRODUCTION OF THE PRODUCT. ONE (1) PHOTOGRAPH OF THE SAMPLE (OPENED) RETURNED WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE OBSERVED BLACK SPECS EMBEDDED (INCLUSIONS) IN THE PLASTIC SHEATH. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. BASED ON AVAILABLE INFORMATION AND THE RESULTS OF THE SAMPLE EVALUATION, THE MOST PROBABLE ROOT CAUSE WAS IDENTIFIED AS BURNT RESIN THAT BROKE LOOSE FROM THE INSIDE OF THE BARREL OF THE INJECTION MOLDING MACHINE AND BECAME EMBEDDED IN THE PLASTIC (INCLUSIONS). THE REPORTED CONDITION PRESENTS NO RISK TO THE PATIENT, BECAUSE THE SPECKS ARE PIECES OF PARENTAL MATERIAL EMBEDDED IN THE PLASTIC SHIELD. THE AVAILABLE INFORMATION INDICATES THE ISSUE WAS MOST LIKELY A RESULT OF AN ISOLATED EVENT, SO FURTHER CORRECTIVE AND PREVENTATIVE ACTION IS NOT DEEMED NECESSARY AT THIS TIME. THE REPORTED CUSTOMER COMPLAINT IS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST PROBABLE ROOT CAUSE WAS IDENTIFIED AS BURNT RESIN THAT BROKE LOOSE FROM THE INSIDE OF THE BARREL OF THE INJECTION MOLDING MACHINE AND BECAME EMBEDDED IN THE PLASTIC (INCLUSIONS). THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES, WHEN OPENING A SEALED PACKAGE, THEY FOUND THERE WAS A BLACK MATERIAL IN ONE OF THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29533 PREVENT NEEDLE ONLY 18 X 1 1/2 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 26551 810057

    Patients

    Seq Age Sex Outcome Treatment
    1