BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC AV FISTULA PACK

    MDR report key: 14304032 · Received May 6, 2022

    Report

    Report Number
    3005011024-2022-00019
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 29, 2022
    Report Date
    June 15, 2022
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756364003
    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 COMPLAINT WAS RECEIVED REPORTING RED SUBSTANCE ON TUBING. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE TUBING SUPPLIER CONMED CORPORATION. THE SAMPLE HAS NOT BEEN RETURNED TO DEROYAL FOR EVALUATION AT THIS TIME. 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 WERE 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 PRACTICES 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. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE TUBING WAS MADE BY DEROYAL, A TOTAL OF 50 WERE 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.

    Description of Event or Problem · 0

    RED SUBSTANCE ON TUBING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079597 CMC AV FISTULA PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10536 56618660 00749756364003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown