BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 24587863 · Received March 13, 2026

    Report

    Report Number
    3003442380-2026-02178
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 22, 2026
    Report Date
    May 5, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019317
    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) SEARCH: A QUERY WAS RUN IN THE EQMS ON 04/MAY/2026 AGAINST "LOT NUMBER" "6011693" AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AT POINT OF APPLICATION (I.E., NOT STICKY, NO ATTACHMENT, OR A FEW MINUTES OF ATTACHMENT). REFER TO IF THE ADHESIVE PATCH LIFTS DURING USE, ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AFTER DIRECT APPLICATION. THE REVIEW CONFIRMED THAT LOT 6011693 WAS ASSOCIATED WITH NON-CONFORMANCE (NC) 2170006, WHICH INVOLVED STERILIZATION PROCESSES. HOWEVER, THIS NONCONFORMANCE IS NOT RELATED TO THE REPORTED FAILURE MODE AND IS 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 04/MAY/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6011693" AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AT POINT OF APPLICATION (I.E., NOT STICKY, NO ATTACHMENT, OR A FEW MINUTES OF ATTACHMENT). REFER TO IF THE ADHESIVE PATCH LIFTS DURING USE, ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AFTER DIRECT APPLICATION. THE COUNT OF COMPLAINTS IS 2. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011693 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 100 AND MANUFACTURED IN THE MULTIVAC14, ON 24/FEB/2025 WITH A TOTAL OF (B)(4) UNITS. SUB-ASSEMBLY: WELDING THE LOT: 5B03017 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN LS06, AND LS07, ON 22/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT: 5B03028 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN LS24, AND LS25, ON 27/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT AN NON-CONFORMANCE (NC) 2170006 WAS FOUND FOR STERILIZATION PROCESS IN THE LOT NUMBER 6011693 AND THEREFORE THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. 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 6011693 AND RELATED MALFUNCTION CODES. TWO COMPLAINTS WERE 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. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 8021545. MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TAPE NOT STICKING EVENT ON (B)(6) 2026. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495627 CONTACT DETACH UNO CONTACT DETACH G29 60/6 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-864A 6011693 05705244019317

    Patients

    Seq Age Sex Outcome Treatment
    1