BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC VASCULAR PACK

    MDR report key: 13480010 · Received February 8, 2022

    Report

    Report Number
    3005011024-2022-00005
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    November 1, 2021
    Report Date
    March 3, 2022
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756366304
    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 (#4900240000-2021-8160) WAS RECEIVED ON 01/25/2022 REPORTING THE SUCTION TUBE WAS DISCOLORED WITH RED FOREIGN OBJECT IN IT. THE STERILE FIELD WAS BROKEN DOWN AND REOPENED PRIOR BEFORE THE PATIENT ENTERED THE ROOM. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE TUBING SUPPLIER CONMED CORPORATION. THE SAMPLE HAS BEEN 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.

    Additional Manufacturer Narrative · 0

    THE TUBING WAS RETURNED TO DEROYAL FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE TUBING SUPPLIER CONMED. POTENTIAL ROOT CAUSE: RAW MATERIAL (RESIN) WITH FOREIGN MATTER FROM CONMED'S SUPPLIER. THE PERSONNEL WAS NOT FOLLOWING THE GOOD MANUFACTURING PRACTICES. THE FOLLOWING CORRECTIVE ACTIONS HAVE TAKEN PLACE BY CONMED: REQUESTED AN INCOMING INSPECTION OF THE RESIN. RETRAINED THE PERSONNEL INVOLVED ON THE QWI-016-M GOOD MANUFACTURING PRACTIES PROCEDURE. UPDATED MANUFACTURING PROCEDURE MP-09-1492-M TO INCLUDE THE INSTRUCTIONS TO MAINTAIN THE GAYLORDS COVERED IN THE EXTRUSION AREA. UPDATED MP-128-M TO CLARIFY THE INSTRUCTIONS FOR VERIFICATION OF RED SUBSTANCE IN THE TUBING DURING THE COILING PROCESS. DEROYAL NO LONGER RECEIVES THIS PRODUCT FROM CONMED. 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.

    Description of Event or Problem · 0

    UPON INSPECTION, THE SUCTION TUBE WAS DISCOLORED WITH RED FOREGIN OBJECT IN IT. THE STERILE FIELD WAS BROKEN DOWN AND REOPENED PRIOR BEFORE THE PATIENT ENTERED THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550795 CMC VASCULAR PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10581 55247060 00749756366304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown