BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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    MDR report key: 24077135 · Received January 14, 2026

    Report

    Report Number
    3003442380-2025-12434
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 18, 2025
    Report Date
    April 8, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018426
    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. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) A QUERY WAS RUN IN THE EQMS ON 08-APR-2026 AGAINST "LOT NUMBER" "6012218" AND SIMILAR MALFUNCTION CODES: OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS- BLOCKAGE, OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED), TUBING IS DAMAGED (E.G., KINKED, DEFORMED, TWISTED, COLLAPSED, OR PINCHED). THE REVIEW CONFIRMED THAT LOT 6012218 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 08-APR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6012218" AND SIMILAR MALFUNCTION CODES: OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS- BLOCKAGE, OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED), TUBING IS DAMAGED (E.G., KINKED, DEFORMED, TWISTED, COLLAPSED, OR PINCHED). THE COUNT OF COMPLAINT IS (B)(4). THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012218 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 101 AND PACKAGING IN THE MULTIVAC 14, ON 13-MAR-2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF WELDING LOT 5C01394 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINES LS06 AND LS07, ON 10-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF WELDING LOT 5B03032 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINES LS24 AND LS25, ON 02-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF GLUING CONNECTOR LOT 5C01351 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE LINE 3, ON 09-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF GLUING CONNECTOR LOT 5C01362 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE LINE 3, ON 10-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF GLUING CONNECTOR LOT 5B02930 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE LINE 3, ON 02-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY OF GLUING CONNECTOR LOT 5B02932 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE LINE 3, ON 04-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6012218 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    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 IN THE TUBING. 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
    386854 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6012218 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female