BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC AV FISTULA PACK

    MDR report key: 15876839 · Received November 29, 2022

    Report

    Report Number
    3005011024-2022-00037
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 11, 2022
    Report Date
    January 6, 2023
    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 ON (B)(6) 2022 REPORTING SUBSTANCE ON THE TUBING. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE TUBING SUPPLIER AMSINO INTERNATIONAL, INC. 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

    A SAMPLE OF THE TUBING WAS PROVIDED TO DEROYAL FOR EVALUATION AND A PICTURE OF THE TUBING WAS SUPPLIED TO AMSINO INTERNATIONAL, INC. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE TUBING SUPPLIER AMSINO INTERNATIONAL, INC. ROOT CAUSE: WAS DETERMINED TO BE UNKNOWN BY THE SUPPLIER AMSINO INTERNATIONAL, INC. AS SPECIFIC DEFECTIVE SAMPLES HAVE NOT BEEN OBTAINED. IT WAS IMPOSSIBLE TO DETERMINE WHAT THE SUBSTANCE WAS, AND IN WHICH LINK THE SUBSTANCE WAS PRODUCED. POTENTIAL ROOT CAUSE DETERMINED BY AMSINO: THE REASON WHY THE BAD SAMPLES ENTERED THE MARKET IS THAT WE DID NOT FIND THE BAD SAMPLES IN TIME AND PICK THEM OUT. THERE MAY BE SOME MATERIAL ON IT DUE TO NEGLIGENCE OF EMPLOYEES IN THE PRODUCTION PROCESS, BUT THERE IS NO SUCH MATERIAL IN OUR PRODUCTION ENVIRONMENT. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE TAKEN PLACE BY AMSINO: RELEVANT QUALITY PERSONNEL AND PRODUCTION PERSONNEL HAVE BEEN TRAINED, AND THE SUBSEQUENT PRODUCTION PROCESS IS REQUIRED TO INCREASE THE SAMPLING AMOUNT FOR INSPECTION, AND THE APPEARANCE OF PACKAGING PRODUCTS IS ALSO REQUIRED TO BE INSPECTED. WE CHECKED THE RETENTION SAMPLES, THE INVENTORY, AND THE PRODUCTS UNDER PRODUCTION, AND FOUND NO SUCH PROBLEMS. STRENGTHEN THE APPEARANCE INSPECTION OF THE PRODUCTS TO 100% INSPECTION, PACKAGING NEEDS TO CHECK THE APPEARANCE BEFORE PACKAGING. THE INSPECTION OF THE OTHER TYPES OF PRODUCTS HAS ALSO BEEN STRENGTHENED, AND PACKAGING CAN ONLY BE CARRIED OUT AFTER 100% COMPLETE INSPECTION. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE TUBING WAS MADE BY DEROYAL, A TOTAL OF 80 OF THE 5-3279 TUBING 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.

    Description of Event or Problem · 0

    SUBSTANCE ON THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535823 CMC AV FISTULA PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10536 57760035 00749756364003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown