BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 21660960 · Received March 21, 2025

    Report

    Report Number
    3003442380-2025-04286
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    January 23, 2025
    Report Date
    June 5, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4). 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6010012 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE TUBING DETACHED FROM HUB COMPLAINT INVESTIGATION. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. REFERENCE SAMPLES TEST RESULTS: ON THE VISUAL INSPECTION ACCORDING TO WI VERSION 3, WAS PERFORMED AND 10/10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST STATI PULL TUBING-TUBING HUB ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: PACKAGING LOT: THE LOT 6010012 WAS PACKAGING ACCORDING TO THE WI VERSION 98, IN THE MACHINE MULTIVAC 14, ON 10/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 4K02983 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65, IN THE MACHINE SC05 AND SC06, ON 06/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05301 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65, IN THE MACHINE SC08, ON 07/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 04-JUN-2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM HUB AND LOT 6010012 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT# 6010012 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON REFERENCE SAMPLES, NO ISSUE WERE FOUND RELATED TO DETACHMENT FROM TUBING-TUBING HUB , HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINT WAS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION, NO FURTHER ACTION ARE REQUIRED, THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES. .

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 1 OF 5.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT EVENT ON (B)(6) 2025. THE SITE OF DETACHMENT WAS TUBING HUB. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308295 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL UM-D 1002833 6010012 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male