BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 21716787 · Received March 28, 2025

    Report

    Report Number
    3003442380-2025-04717
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    January 29, 2025
    Report Date
    September 2, 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

    INITIAL AND FINAL MDR (B)(4) - DEVICE 2 OF 5.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4). CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED LOT NUMBER, EXPIRATION DATE UNDER D4. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. REVISION 21 OF 3709030 DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010012, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010012 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 98 AND PACKAGING IN THE MULTIVAC 14 ON 10/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. DURING THE OUTGOING TEST 8, ONE SAMPLE WAS FOUND WITH BENT STEEL NEEDLE. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 4K02983 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED ON THE MACHINES SC05 & SC06, ON 06/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 4K05301 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC08, ON 07/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: AN EXTENDED WAS RAISED DURING THE OUTGOING TEST 8 UNRELATED TO COMPLAINT CODE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON (B)(6) 2025 WHERE INFUSION SET TUBING WAS DETACHED FROM HUB. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 520 MG/DL WHICH WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION. THE ISSUE OCCURRED WITH FIVE SIMILAR TYPE OF INFUSION SETS USED FOR ONE DAY. THE CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    2658833 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