BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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    MDR report key: 24738326 · Received March 31, 2026

    Report

    Report Number
    3003442380-2026-99888
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    January 28, 2024
    Report Date
    February 25, 2026
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A 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 14-MAR-2026 THIS 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 THIS INVESTIGATION HAS BEEN UPDATED BECAUSE THE MALFUNCTION CODE CHANGED FROM LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE) TO LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS, WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 07-FEB-2024. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, THE FOLLOWING ELEMENTS WERE ADDED TO ALIGN WITH CURRENT INVESTIGATION REQUIREMENTS: COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM SEARCH: A QUERY WAS RUN IN THE EQMS ON 13-MAR-2026 AGAINST "LOT NUMBER" "6002653" AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS. THE REVIEW CONFIRMED THAT LOT 6002653 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON CONFORMANCE REPORT OR CORRECTIVE AND PREVENTIVE ACTION OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 13-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6002653" AND SIMILAR MALFUNCTION CODES: LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS THE NUMBER OF COMPLAINTS IS (B)(4). THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). DHR REVIEW: THE LOT 6002653 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION VERSION 94 AND MANUFACTURED IN THE M10 MACHINE ON 04-AUG-2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY LOT 3G05862 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 31 AND ASSEMBLED IN THE MACHINE LS06 ON 01-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3C05884 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 32 AND ASSEMBLED IN THE MACHINE LS25, ON 04-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G05851 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 31 AND ASSEMBLED IN THE MACHINE LS07 ON 01-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G05886 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 32 AND ASSEMBLED IN THE MACHINE LS24 ON 03-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G04688 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 35 AND ASSEMBLED IN THE GLUEING 3 LINE ON 01-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3G05128 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 35 AND ASSEMBLED IN THE GLUEING 3 LINE ON 02-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3H00550 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 55 AND ASSEMBLED IN THE MACHINE SPOT 06 ON 03-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3H00549 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 55 AND ASSEMBLED IN THE MACHINE SC05 ON 04-AGO-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: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WORK INSTRUCTION (MONTHLY TRIPS AND ALERTS). 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 6002653 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). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE MALFUNCTION REMAINS UNCONFIRMED 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 INFUSION TUBING DETACHMENT FROM CONNECTOR ISSUE EVENT ON (B)(6) 2024. THE INFUSION SET WAS USED FOR TWELVE TO FOURTEEN HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801842 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL UM-D 1002833 6002653 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female