BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 25172603 · Received May 14, 2026

    Report

    Report Number
    3003442380-2026-17478
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    September 14, 2025
    Report Date
    May 11, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). NAME: MEDTRONIC MINIMED COUNTRY: UNITED STATES OF AMERICA STREET: 18000 DEVONSHIRE STREET CITY: NORTHRIDGE STATE, PROVINCE OR TERRITORY: CALIFORNIA POST OFFICE OR ZIP CODE: 91325. IMDRF CAUSE INVESTIGATION CODE: CODE B24 IS NOT AVAILABLE IN DATABASE TO CAPTURE EVENT HISTORY LOG REVIEW IMDRF INVESTIGATION FINDINGS CODE C22 (APPROPRIATE TERM/CODE NOT AVAILABLE) HAS BEEN SELECTED, AS CODE C24 IS NOT AVAILABLE IN THE DATABASE TO CAPTURE (MALFUNCTION OBSERVED WITHOUT CONCLUSIVE FINDING). 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 23-MAR-2026 AGAINST "LOT NUMBER" 6001153 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE. SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE. SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE. SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE REVIEW CONFIRMED THAT LOT 6001153 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 23-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6001153 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE. SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE. SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE. SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. NO ESCALATION REQUIRED. THE COUNT OF COMPLAINTS IS 5. THE COMPLAINT NUMBER IS (B)(4). RETAIN SAMPLES TESTING: RETAIN SAMPLES FROM THE RELEVANT LOT WERE REQUESTED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA (VERSION 3): ALL 3 SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA (VERSION 2): ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4) TEST REPORT. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. RETURN SAMPLES TESTING: RETURNED SAMPLES FROM THE RELEVANT LOT WERE RETURNED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA (VERSION 3): 1 USED SOFT CANNULA WAS FOUND TO BE KINKED AT THE TIP. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA (VERSION 2): 1 USED CANNULA TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4) TEST REPORT. ALL TEST RESULTS WERE DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT 2398085 TEST REPORT. CONCLUSION: VISUAL INSPECTION CONFIRMED THE REPORTED ISSUE; ESCALATION FOR CAPA AND FURTHER INVESTIGATION REQUIRED PER QUALITY PROCEDURES. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE ABOVE INVESTIGATION, FURTHER INVESTIGATION WAS REQUIRED BECAUSE THE FOLLOWING THRESHOLD WAS MET 3 OR MORE COMPLAINTS EXIST FOR THE SAME LOT AND SIMILAR MALFUNCTIONS. STATISTICAL ANALYSIS RESULT: AFTER ASSESSMENT OF THE FAILURE VIA PRODUCT TRENDING OVER TIME WITH CONTROL CHARTS, THE RISK HAS BEEN DEEMED AS WITHIN ACCEPTED LIMITS. NO FURTHER ACTION IS REQUIRED. SEE ATTACHMENT: FORM-MMT-387A600 SIGNED, COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORT FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: THE INVESTIGATION INCLUDED A COMPREHENSIVE REVIEW OF EQMS RECORDS, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD VERIFICATION, AND ASSESSMENT OF THE VISUAL EVIDENCE PROVIDED. NO NCRS, CAPAS, OR QUALITY EVENTS OF THE SAME OR SIMILAR NATURE WERE IDENTIFIED FOR LOT 6001153 OR THE ASSOCIATED MALFUNCTION CODE. SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE. THE SAMPLES SUPPLIED BY THE CUSTOMER CORROBORATED THE REPORTED CONDITION, CONFIRMING THAT THE PHYSICAL EVIDENCE SUPPORTS THE COMPLAINT. ALL AVAILABLE DOCUMENTATION AND ANALYSIS INDICATE THAT THE ISSUE IS ISOLATED AND NOT LINKED TO SYSTEMIC MANUFACTURING OR QUALITY CONCERNS. STATISTICAL EVALUATION AND PRODUCT FAMILY TRENDING CONFIRMED THAT THE RISK ASSOCIATED WITH THIS MALFUNCTION REMAINS WITHIN ACCEPTABLE LIMITS. BASED ON THESE FINDINGS, NO ADDITIONAL INVESTIGATION OR CORRECTIVE ACTIONS ARE REQUIRED. THE RECORD WILL BE CLOSED AND WILL CONTINUE TO BE MONITORED THROUGH ROUTINE TRACKING AND TRENDING ACTIVITIES. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE SERIOUS INJURY. 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

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCED HIGH BLOOD GLUCOSE LEVELS ON (B)(6) 2025 DUE TO BENT CANNULA ON FIRST DAY OF USE. THE PATIENT WAS TREATED WITH INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326491 QUICK SET SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V MMT-387A600 6001153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown