BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 20743085 · Received November 21, 2024

    Report

    Report Number
    3003442380-2024-32698
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL A/S
    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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001313, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 27/NOV/2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6001313". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001313 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 AND PACKAGING IN THE MACHINE MULTIVAC 12 ON 15/MAY/2023 WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCES (NC) WAS RAISED DUE TO STERILIZATION ISSUES. THIS NC IS NOT RELATED TO CLAIMED MALFUNCTION. FURTHERMORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. TEST RESULTS: NO PHOTO WAS PROVIDED. TO PROCEED WITH PRODUCT TESTING, SAMPLES FROM THE AFFECTED LOT WERE REQUESTED. HOWEVER, THE CUSTOMER HAS CONFIRMED THAT NO SAMPLES ARE AVAILABLE FOR INVESTIGATION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES OR PHOTOGRAPHIC EVIDENCE HAVE BEEN SUBMITTED FOR ANALYSIS, ONE NONCONFORMANCE (NC) WAS RAISED DURING THE STERILIZATION PROCESS, AND FOUND UNRELATED TO THE REPORTED MALFUNCTION CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND FINAL REPORTING DECISION, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR 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 UNITED ARAB EMIRATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET MISSHAPED PACKAGING EVENT ON 23-OCT-2024. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50272 MINMED QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6001313 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown