BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVENT NEEDLE ONLY 18 X 1 1/2

    MDR report key: 8256495 · Received January 17, 2019

    Report

    Report Number
    1017768-2019-00558
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 22, 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

    SECTION D4 CORRECTION: SAMPLE RECEIVED IDENTIFIED LOT NUMBER AS 810057. NO LOT NUMBER WAS PROVIDED WITHIN INITIAL REPORT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 810057 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. 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 IS NOT COLLECTED FOR THE MOLDING MACHINE. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND REVEALED NO ISSUES. A REVIEW OF THE ENTIRE DHR FOUND NO MANUFACTURING OR INSPECTION ANOMALIES. DHRS WERE ALSO REVIEWED FOR THE NEEDLES ASSEMBLED FOR THIS LOT. PHYSICAL SAMPLES INSPECTED FROM THE SHOP ORDERS IDENTIFIED NO ISSUES OR NCRS ISSUED AGAINST THE SHOP ORDERS. IN ADDITION, REVIEW FOR NONCONFORMANCE FOUND NO NCRS ISSUED AGAINST THE MOLDED HUBS OR THE MOLDED SHIELDS USED IN PRODUCTION OF THIS PRODUCT. ONE (1) SAMPLE (OPENED) WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OBSERVED BLACK SPECS. UPON REVIEW OF THE SAMPLE UNDER MAGNIFICATION, IT WAS DISCOVERED THAT THE SPECS WERE EMBEDDED (INCLUSIONS) IN THE PLASTIC HUB AND PLASTIC SHIELD. THE SPECS COULD NOT BE REMOVED BY PHYSICAL (WIPING) OR CHEMICAL (ISOPROPYL 70% ALCOHOL) MEANS. THE REPORTED CONDITION IS CONFIRMED. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. HOWEVER, 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 EVENT PRESENTS NO RISK TO THE PATIENT, BECAUSE THE SPECKS WERE EMBEDDED IN THE PLASTIC HUB AND PLASTIC SHIELD. THE CONDITION WAS MOST LIKELY CREATED DURING A RANDOM EVENT DURING THE MOLDING PROCESS. THERE¿S NO INDICATION OF A SYSTEMIC ISSUE WITH THE PROCESS OR PRODUCT. THE REPORTED CUSTOMER COMPLAINT IS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. A PROBABLE ROOT CAUSE WAS IDENTIFIED TO BE 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 UTILIZED 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.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THERE WAS BLACK MATERIAL IN ONE OF THE NEEDLES INSIDE A SEALED PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48505 PREVENT NEEDLE ONLY 18 X 1 1/2 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 26551 810057

    Patients

    Seq Age Sex Outcome Treatment
    1