BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURE-T PARADIGM

    MDR report key: 19936561 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19341
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244019348
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY:(B)(4). PATIENT COUNTRY: UNITED STATES.

    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. LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) THE LOT 6000329 IN QUESTION WAS PRODUCED AT REYNOSA 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 AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION ACCORDING TO (VERSION 17) MODEL SAMPLE (MUESTRARIO DE LOS MODELOS) CONTACT DETACH, NERIA MULTI Y TRUSTEEL - SAMPLER FOR CONTACT, CONTACT DETACH, NERIA MULTI .DOC FUNCTIONAL TEST 1: (VERSION 9) QUALITY SPECIFICATION FOR FLOW TESTING OF PRODUCTS STEEL.DOC (ESPECIFICACIÓN DE CALIDAD PARA LA PRUEBA DE FLUJO DE LOS PRODUCTOS STEEL.DOC) FUNCTIONAL TEST 2: (VERSION 25) INSTRUCTIONS FOR THE USE OF LEAK EQUIPMENT IN THE INSPECTION AREA.DOC (INSTRUCCIONES PARA EL USO DEL EQUIPO DE FUGA EN EL AREA DE INSPECCION.DOC) BATCH REVIEW THE BATCH LISTED IN THE DATABASE COMPLAINT PARENT RECORD WAS REVIEWED AND CONFIRMED TO BE ACCURATE. UNO CONTACT DETACH G29 80/6 SC1 MIMX WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1728383 AND MANUFACTURING LOT NUMBER 6000329 ON 19-MAR-2023. (B)(4) FINAL UNITS IN THE MACHINE 9,10,14 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 IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKING EVENT ON 08-JUL-2024 . THE INFUSION SET WAS IN USE FOR 1 DAY. 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
    2396099 SURE-T PARADIGM UNO CONTACT DETACH G29 80/6 SC1 MIMX FPA UNOMEDICAL A/S MMT-866A 6000329 05705244019348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown