BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 GAL CHEMO RED SLIDE LID

    MDR report key: 8013949 · Received October 29, 2018

    Report

    Report Number
    1424643-2018-00510
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    September 21, 2018
    Report Date
    January 29, 2019
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 18002363 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. ADDITIONALLY, THE DHR WAS REVIEWED (LOT NO. 183690) FOR SUBASSEMBLY UTILIZED IN THE PRODUCTION OF THIS PRODUCT. THE LOT WAS RELEASED MEETING ALL ACCEPTANCE CRITERIA. NO PRODUCT/SAMPLE WAS PROVIDED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. THEREFORE, A COMPREHENSIVE INVESTIGATION WAS UNABLE TO BE CONDUCTED. THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE OF THIS EVENT COULD BE ATTRIBUTED TO GASKET MATERIAL UNDER THE LIFTER. THIS CAN OCCUR WHEN THE ROBOT EOAT PROGRAMMED START/STOP POSITION IS LOCATED UNDER THE LIFTER AT THE TIME OF PRODUCTION. HOWEVER, WITHOUT A SAMPLE, CANNOT BE AFFIRMED. 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. 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 STATED THAT THE LIDS ON THE CONTAINERS DO NOT SEAL PROPERLY. THE LIDS SOMETIMES POP OFF WHEN TAKING BIN OFF CART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854776 18 GAL CHEMO RED SLIDE LID CONTAINER, SHARPS MMK COVIDIEN 8939CRS 18002363

    Patients

    Seq Age Sex Outcome Treatment
    1