BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 22891973 · Received August 26, 2025

    Report

    Report Number
    3003442380-2025-13208
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 5, 2025
    Report Date
    October 8, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K991759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-13208), WAS SUBMITTED ON 26-AUG-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 22-JUN-2023. 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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001972, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001972 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77 AND PACKAGING IN THE MULTIVAC M12 ON 22-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 3F03094 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND ASSEMBLED IN THE QUICKSET LINE, ON 27-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 3F04118 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND ASSEMBLED IN THE QUICKSET LINE, ON 27-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY OF THE LOT 3F03093 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND ASSEMBLED IN THE QUICKSET LINE, ON 27-JUN-2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6), PATIENT COUNTRY: UNITED ARAB EMIRATES

    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 ARAB EMIRATES IT WAS REPORTED THAT PATIENT FACED AN EVENT WHERE NEEDLE WAS BROKEN ON (B)(6) 2025 DURING INSERTION. INSERTION SITE WAS ARM. THE INFUSION SET WAS IN USE FOR FEW SECONDS. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722695 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6001972 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown