BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 22684048 · Received August 1, 2025

    Report

    Report Number
    3003442380-2025-12129
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 10, 2025
    Report Date
    October 30, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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. PER REVISION 21 OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DEVICE HISTORY RECORD (DHR) REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6013137, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013137 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND MANUFACTURED IN THE MACHINE MULTIVAC 14 ON 02/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. GLUE-CONNECTOR LOT: THE LOT 5E01644 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE MP03 ON 13/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D02709 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE MP03 ON 30/APR/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D04877 WAS MANUFACTURED ACCORDING TO THE WI VERSION 39 AND MANUFACTURED IN THE MACHINE MP03 ON 30/APR/2025, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED THAT DURING OUTGOING TEST 8, ONE EXTENDED SAMPLING WAS RAISED: ONE FOR CROOCKED NEEDLE. ONE EXTENDED SAMPLING WAS ACCEPTED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) CONFIRMS THAT ALL REQUIRED TESTS RELATED TO THE PROCESS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, 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

    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 THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS AT THE SITE. THE BLOOD GLUCOSE LEVEL WAS NOT HIGH AT THE TIME OF EVENT BUT THE PATIENT TOOK MULTIPLE DAILY INJECTION (MDI) TO CONTROL HIS/HER BLOOD GLUCOSE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224190 CONTACT DETACH UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002835 6013137 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female