BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23601309 · Received November 19, 2025

    Report

    Report Number
    3003442380-2025-16783
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 3, 2025
    Report Date
    December 30, 2025
    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

    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. ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 30-DEC-2025 AGAINST "LOT NUMBER 6012105 AND SIMILAR MALFUNCTION CODE(S): TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE), COMPONENT DEFECT- MALFUNCTION CODE NOT ON LIST. THE REVIEW CONFIRMED THAT LOT 6012105 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 30-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6012105 AND SIMILAR MALFUNCTION CODES TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) COMPONENT DEFECT- MALFUNCTION CODE NOT ON LIST. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012105 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC M12 ON 11/MAR/2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, OF THE LOT 5C00139 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN THE QUICKSET LINE, ON 10/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, OF THE LOT 5C00140 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN THE QUICKSET LINE, ON 11/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, OF THE LOT 5C00141 WAS MANUFACTURED ACCORDING TO THE WI VERSION 29 AND MANUFACTURED IN THE QUICKSET LINE, ON 11/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 5B04989 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 04 - 08, ON 07/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING, OF THE LOT 5C00159 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 04 - 08, ON 09/MAR/2025, 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 WI (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 6012105 AND RELATED MALFUNCTION CODES FOR TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE). 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. FOR MORE DETAILS SEE THE INFORMATION UNDER THE CHILD INV RECORD (B)(4).

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHMENT ON (B)(6) 2025 WHICH LED TO THE HIGH BLOOD GLUCOSE LEVEL. THE LOCATION OF DETACHMENT WAS AT SITE. THE BLOOD GLUCOSE LEVEL WAS 154 MG/DL AND THE PATIENT GOT TREATED WITH MANUAL INJECTIONS. THE INFUSION SET WAS IN USE FOR THREE DAYS. THE INSERTION SITE WAS LEFT ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309599 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6012105 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown