BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC VASCULAR ACCESS PACK

    MDR report key: 17390795 · Received July 25, 2023

    Report

    Report Number
    3005011024-2023-00031
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    June 23, 2023
    Report Date
    August 9, 2023
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756363495
    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 7/13/2023 REPORTING UNIDENTIFIED MATERIAL NOTICED ON RAYTECS. THE ACTUAL SAMPLE WAS NOT RETURNED TO DEROYAL FOR EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE RAYTEC SUPPLIER MEIXIN MEDICAL SUZHOU CO., LTD. THE FOLLOWING ROOT CAUSE WAS DETERMINED BY THE SUPPLIER MEIXIN MEDICAL SUZHOU CO., LTD: THE UNIDENTIFIED MATERIAL REPORTED BY THE CUSTOMER MAY BE THE RESIDUAL COTTON SEED SHELLS OR FOREIGN FIBERS THAT WERE LEFT ON THE COTTON FIBERS. THE WORKERS FAILED TO DETECT THESE FOREIGN MATTERS DURING PRODUCTION, AND THE CONTAMINATED PRODUCTS ESCAPED TO THE NORMAL LINE. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN BY MEIXIN MEDICAL SUZHOU CO., LTD: NOTIFY THE RAW MATERIAL SUPPLIER OF THIS REPORTED ISSUE. STRESS THAT WORKERS OF EACH PRODUCTION PROCESS SHALL STRICTLY FOLLOW THE SPECIFICATION PROCEDURE. THE FOLDING WORKERS SHALL STOP THE MACHINE TO REMOVE THE NONCONFORMING PRODUCTS IF DETECT ANY FOREIGN MATTERS. THE SUBSEQUENT INSPECTION WORKERS SHALL INSPECT CAREFULLY TO PREVENT CONTAMINATED PRODUCTS ESCAPING TO THE NORMAL LINE. RETRAIN THE WORKERS ON RELATED OPERATION PROCEDURE AND QUALITY STANDARD TO ENHANCE THEIR QUALITY AWARENESS. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE GAUZE WAS MADE BY DEROYAL, A TOTAL OF (B)(4) OF THE 5-19928 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.

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON 7/13/2023 REPORTING UNIDENTIFIED MATERIAL NOTICED ON RAYTECS. THE ACTUAL SAMPLE HAS NOT BEEN RETURNED TO DEROYAL FOR EVALUATION AT THIS TIME. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE RAYTEC SUPPLIER MEIXIN MEDICAL SUZHOU CO., LTD. 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

    UNIDENTIFIED MATERIAL NOTICED ON RAYTECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843149 CMC VASCULAR ACCESS PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10578 58774990 00749756363495

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown