BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19947337 · Received August 9, 2024

    Report

    Report Number
    3003442380-2024-20435
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    June 24, 2024
    Report Date
    August 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018488
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY. THE COMPLAINT (B)(4) HAS BEEN EVALUATED ACCORDING TO MALFUNCTION. OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). THE LOT 6000890 IN QUESTION WAS PRODUCED AT REYNOSA ID SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) VERSION 11. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION ACCORDING TO VERSION 12 QUALITY SPECIFICATION FOR THE CONNECTOR-TUBE GLUING PROCESS ON THE SPOT CURING MACHINES. VERSION 18 MUESTRARIO DEL AREA DE EXTRUDER Y ENRROLLADO DE TUBO (SAMPLER OF THE EXTRUDER AND TUBE COILING AREA). FUNCTIONAL TEST 1: VERSION 9 ESPECIFICACIÓN DE CALIDAD PARA LA PRUEBA DE FLUJO DE LOS PRODUCTOS STEEL.DOC (QUALITY SPECIFICATION FOR FLOW TESTING OF STEEL.DOC PRODUCTS). BATCH REVIEW THE BATCH LISTED IN THE DATABASE COMPLAINT PARENT RECORD WAS REVIEWED AND CONFIRMED TO BE ACCURATE. UNO CONTACT DETACH G29 60/8TCAP 10PK INTINT WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1726020 AND MANUFACTURING LOT NUMBER 6000890 ON 14-MAY-2023. (B)(4) FINAL UNITS IN THE MACHINE (B)(4) WERE MANUFACTURED. THE BATCH RECORD CONFIRMS THIS INFORMATION. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO DEFECT ON TEST, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 24-JUNE-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION FLOW BLOCKED AND TUBING DISCONNECTED AT THE SITE. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635064 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002835 6000890 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male