BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 24712629 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99437
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    January 2, 2024
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018457
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 2 OF 2. UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA)/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 13-MAR-2026 THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. 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) SEARCH: A QUERY WAS RUN IN THE EQMS ON 12-MAR-2026 AGAINST LOT NUMBER 6002435 AND SIMILAR MALFUNCTION CODES: TUBING IS SPLIT (ALONG THE LENGTH OF THE TUBING) OR HAS PINHOLES, TUBING DAMAGE - SIGNIFICANT / EXTENSIVE. THE REVIEW CONFIRMED THAT LOT 6002435 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON-CONFORMANCE REPORT (NCR) OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 12-MAR-2026 AGAINST LOT NUMBER CRITERIA EQUAL 6002435 AND SIMILAR MALFUNCTION CODES: TUBING IS SPLIT (ALONG THE LENGTH OF THE TUBING) OR HAS PINHOLES, TUBING DAMAGE - SIGNIFICANT / EXTENSIVE. THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002435 WAS MANUFACTURED ACCORDING TOWORK INSTRUCTION (WI) VERSION 94 AND MANUFACTURED IN THE MACHINE M10, ON 20-JUL-2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY: LOT 3G02910 WAS MANUFACTURED ACCORDING TO THE WI VERSION 31 AND ASSEMBLED IN THE MACHINE LS 24, ON 19-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G02916 WAS MANUFACTURED ACCORDING TO THE WI VERSION 31 AND ASSEMBLED IN THE MACHINE LS 25, ON 21-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G02834 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND ASSEMBLED IN THE GLUEING 3 LINE, ON 18-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G02835 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND ASSEMBLED IN THE GLUEING 3 LINE, ON 19-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3F03030 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND ASSEMBLED IN THE MACHINE SPOT 05, ON 17-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3F03289 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND ASSEMBLED IN THE MACHINE SC06, ON 21-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G04052 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND ASSEMBLED IN THE MACHINE SPOT 06, ON 21-JUL-2023, 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: 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 6002435 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. FOR MORE DETAILS SEE THE INFORMATION UNDER THE CHILD INVESTIGATION RECORD (B)(4). CAPA DETERMINATION: NO CAPA REQUIRED. COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN ISSUE WITH TWO INFUSION SETS ON (B)(6) 2024 AS THE TUBING WAS SPLIT AND INSULIN WAS LEAKING THROUGHT THE TUBING. THE INFUSION SET WAS IN USE FOR ABOUT THREE HOURS. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 589 MG/DL AND HAD SMALL KETONES. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778839 CONTACT DETACH UNO CONTACT DETACH G29 80/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002834 6002435 05705244018457

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male