BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23677441 · Received November 30, 2025

    Report

    Report Number
    3003442380-2025-17071
    Event Type
    Malfunction
    Date Received
    November 30, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 26, 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

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: ARGENTINA.

    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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 2448524, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013885 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI)VERSION 82 AND PACKAGING IN THE MULTIVAC # M12 ON 02-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. NOTE: REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN COMPLETED AND MET THE REQUIREMENTS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT DURING OUTGOING TEST 9 AN EXTENSION DUE TO SILICONE WAS FOUND WHEN PERFORMING ASSEMBLY TESTS ON TWO SAMPLES AND, THEREFORE, THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN COMPLETED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR WERE ANY MAINTENANCE EVENTS RECORDED RELATED TO THE COMPLAINT CODE. THE SUB-ASSEMBLY: ASSEMBLY: THE LOT 5F02828 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND ASSEMBLED IN THE QUICKSET LINE, ON 25-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F02829 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND ASSEMBLED IN THE QUICKSET LINE, ON 26-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5F02830 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND ASSEMBLED IN THE QUICKSET LINE, ON 26-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING: THE LOT 5F02593 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE LINE MP04-MP08, ON 24-JUN-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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, ONE OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AGRENTINA. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2025. THE LOCATION OF DETACHMENT WAS AT THE SITE. THE SITE OF INSERTION WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842559 QUICK SET UNO QUICK-SET 60/9 SC1 MECAINT FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6013885 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown