BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 24593837 · Received March 13, 2026

    Report

    Report Number
    3003442380-2026-02300
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 21, 2026
    Report Date
    March 10, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2026-02300. 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 09-MAR-2026 AGAINST "LOT NUMBER 6013750 AND SIMILAR MALFUNCTION CODE(S): 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 6013750 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 09-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013750 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 COUNT OF COMPLAINT IS 4. THE COMPLAINT NUMBERS ARE (B)(4). ESCALATE TO CAPA DETERMINATION FOR STATISTICAL ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013750 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82, IN THE MACHINE MULTIVAC 12, ON 09/JUN/2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 5F01511 WAS ASSEMBLED ACCORDING TO WI VERSION 30 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 09-JUN2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F01512 WAS ASSEMBLED ACCORDING TO WI VERSION 30 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 09-JUN2025, WITH A TOTAL OF (B)(4) UNITS. THE DHR REVIEW INDICATED THAT DURING OUTGOING TEST 9, ONE SAMPLE WAS FOUND WITH DELAMINATED ADHESIVE TAPE. AN EXTENDED SAMPLING WAS CONDUCTED AND ACCEPTED IN ACCORDANCE WITH ESTABLISHED PROCEDURES, THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW IDENTIFIED MINOR FINDING. IT WAS MANAGED ACCORDING TO PROCEDURE AND DID NOT IMPACT COMPLIANCE; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. RETURN SAMPLES TESTING: RETURNED SAMPLES FROM THE RELEVANT LOT WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. 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 MALFUNCTION(S). 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. 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 6013750 AND RELATED MALFUNCTION CODES FOR SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, MORE THAN 3 COMPLAINTS WERE IDENTIFIED FOR THIS LOT AND BASED ON THE ASSESSMENT OF THE MALFUNCTION AND PRODUCT FAMILY TRENDING OVER TIME, THE RISK HAS BEEN DEEMED WITHIN ACCEPTED LEVEL. 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). -MDR .

    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 DENMARK IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE BENT CANNULAS, WHICH LED TO HIGH BLOOD GLUCOSE LEVEL EVENT ON (B)(6) 2026. THE INSERTION SITE WAS BUTTOCKS. THE INFUSION SET WAS IN USE FOR FEW HOURS. THE PATIENTS BLOOD GLUCOSE LEVEL WAS OVER 20MMOL/L. DURING EVENT, THE PATIENT WAS TREATED WITH INSULIN VIA PUMP AND PEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33025 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6013750 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown