BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC VASCULAR PACK

    MDR report key: 16086302 · Received January 3, 2023

    Report

    Report Number
    3005011024-2022-00051
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    November 14, 2022
    Report Date
    January 13, 2023
    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 REPORT (B)(4) WAS RECEIVED ON 12/08/2022 REPORTING PITCHER HAD BLACK SPOTS. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE PITCHER SUPPLIER ROYAL PRECISION PLASTICS. 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 SAMPLE WAS PROVIDED TO DEROYAL FOR EVALUATION. THE SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS CANCELED, AND THE COMPLAINT WAS FORWARDED TO ROYAL PRECISION PLASTICS FOR A JOINT INVESTIGATION BECAUSE THEY ARE CONSIDERED AN INTERNAL DEROYAL FACILITY. THE ROOT CAUSE WAS DETERMINED TO BE EMBEDDED CONTAMINATION FROM DEGRADED MATERIAL THAT HAS BROKEN LOOSE AND PASSED THROUGH WITH MOLTEN PLASTIC INTO THE MOLDED PART. DEGRADE OCCURS WHEN PLASTIC IS SITTING IN A HEATED BARREL FOR A PROLONGED PERIOD OF TIME. NO CORRECTIVE ACTIONS WERE TAKEN DUE TO OCCASIONAL BLACK SPECKS ARE A RESULT OF THE NORMAL INJECTION-MOLDING PROCESS OF POLYOLEFINS AND ARE UNAVOIDABLE IN RELATIVELY SMALL QUANTITIES. AS A PREVENTIVE ACTION IN AN EFFORT TO REDUCE THE POTENTIAL OF EMBEDDED CONTAMINATION, THE INJECTION-MOLDING MACHINE'S SCREW IS CLEANED AT LEAST ANNUALLY. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE PITCHER WAS MADE BY DEROYAL, A TOTAL OF 50 OF THE HD-395-1200-T 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

    PITCHER HAD BLACK SPOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523863 CMC VASCULAR PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10581 57603751 00749756366304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown