BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23519893 · Received November 11, 2025

    Report

    Report Number
    3003442380-2025-16060
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 8, 2025
    Report Date
    December 24, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    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. COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 23-DEC-2025 AGAINST "LOT NUMBER" 6013471 AND SIMILAR MALFUNCTION CODE(S): TUBING DETACHED FROM TUBING-TUBING CONNECTOR, LEAK BETWEEN TUBING AND SITE CONNECTOR DETACHMENT / SIGNIFICANT WETNESS. THE REVIEW CONFIRMED THAT LOT 6013471 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 23-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013471 AND SIMILAR MALFUNCTION CODE(S): TUBING DETACHED FROM TUBING-TUBING CONNECTOR, LEAK BETWEEN TUBING AND SITE CONNECTOR DETACHMENT / SIGNIFICANT WETNESS. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013471 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 26-MAY-2025 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: THE LOT 5E03513 WAS ASSEMBLED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30AND MANUFACTURED ON 25-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E04122 WAS ASSEMBLED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30 AND MANUFACTURED ON 26-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E03514 WAS ASSEMBLED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30 AND MANUFACTURED ON 25-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E04123 WAS ASSEMBLED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30 AND MANUFACTURED ON 26-MAY-2025, WITH A TOTAL OF 29,213 UNITS. GLUING OF TUBING OF THE LOT 5E03432 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08, ON 24-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5E03433 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08, ON 26-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5E03435 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08, ON 26-MAY-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. CORRECTIVE AND PREVENTIVE ACTION (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-001031 (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 6013471 AND RELATED MALFUNCTION CODES FOR TUBING DETACHED FROM TUBING-TUBING CONNECTOR. 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 INV RECORD (B)(4).

    Additional Manufacturer Narrative · 0

    (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 UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2025. THE SITE OF DETACHMENT WAS TUBING CONNECTOR. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE INSERTION SITE WAS ABDOMEN NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615755 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6013471 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown