BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC POSTERIOR SPINE PACK

    MDR report key: 16573720 · Received March 20, 2023

    Report

    Report Number
    3005011024-2023-00015
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 22, 2023
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756363587
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED ON 3/2/2023 RAYTECS IN POSTERIOR SPINE PACK FAULTY, THE X-RAY DETECTABLE STRIP IS EASILY REMOVED FROM RAYTEC SPONGE. STRING CAME OUT WHILE CLEANING KERRISON. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE RAYTEC SUPPLIER MEIXIN MEDICAL. THE ACTUAL SAMPLE WAS NOT AVAILABLE TO BE RETURNED TO DEROYAL FOR EVALUATION. THE FOLLOWING ROOT CAUSE WAS DETERMINED BY THE SUPPLIER MEIXIN MEDICAL: EMPLOYEE FAILED TO REMOVE THE NONCONFORMING PRODUCT FROM THE LINE. THERE WAS NO INVENTORY OR WORK IN PROCESS ON HAND TO EVALUATE. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN BY MEIXIN MEDICAL: ADD REQUIREMENT TO REGULARLY MONITOR THE TEMPERATURE CONTROL DEVICE WHICH WILL AFFECT THE IRONING EFFECT OF THE XR STRIP ON TO THE SPONGE. ONCE DEVIATION IS NOTICED ON THE TEMPERATURE CONTROL DEVICE, PRODUCTION SHOULD BE STOPPED IMMEDIATELY, AND THE SPONGES PRODUCED BEFORE THE DEVIATION SHOULD BE CAREFULLY CHECKED. RETRAIN THE EMPLOYEES ON THE DOCUMENT OF MX/QA-GS-04 GAUZE MECHANICAL FOLDING PROCEDURE TO ENHANCE THEIR QUALITY AWARENESS. STRESS THAT THE EMPLOYEES SHALL STRICTLY FOLLOW THE REGULAR MONITORING REQUIREMENT ON THE TEMPERATURE CONTROL DEVICE, TO ELIMINATE NONCONFORMANCE. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE GAUZE WAS MADE BY DEROYAL, A TOTAL OF 10 OF THE 5-19928 GAUZE WAS INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (#(B)(4)) WAS RECEIVED ON 3/2/2023 RAYTECS IN POSTERIOR SPINE PACK FAULTY, THE X-RAY DETECTABLE STRIP IS EASILY REMOVED FROM RAYTEC SPONGE. STRING CAME OUT WHILE CLEANING KERRISON. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE RAYTEC SUPPLIER MEIXIN MEDICAL. THE ACTUAL SAMPLE WAS NOT AVAILABLE TO BE RETURNED TO DEROYAL FOR EVALUATION. THIS INVESTIGATION IS ONGOING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    RAYTECS IN POSTERIOR SPINE PACK FAULTY, THE X-RAY DETECTABLE STRIP IS EASILY REMOVED FROM RAYTEC SPONGE. STRING CAME OUT WHILE CLEANING KERRISON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766732 CMC POSTERIOR SPINE PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10570 58388870 00749756363587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown