BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 24715351 · Received March 30, 2026

    Report

    Report Number
    3003442380-2026-99504
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    October 31, 2023
    Report Date
    February 25, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017337
    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: POLAND. UNOMEDICAL HEREBY SUBMITS THIS INITIAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA)/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS INITIAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED BASED ON THE REVIEW COMPLETED ON 25-FEB-2026 AND INVESTIGATION COMPLETED ON 11-MAR-2026 THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED AS THE INITIAL REPORT. 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: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR CLICK AND STATIC PULL. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE BATCH RECORD 6000471 WAS VERIFIED AND IT WAS FOUND WITHIN SPECIFICATIONS. THIS INVESTIGATION HAS BEEN UPDATED BECAUSE THE MALFUNCTION CODE CHANGED FROM, WHICH REQUIRES ADDITIONAL ACTIVITIES NOT INCLUDED IN THE ORIGINAL INVESTIGATION DATED 06/NOV/2023. THE ORIGINAL INVESTIGATION REMAINS VALID AND HAS NOT BEEN MODIFIED. AS PART OF THIS REASSESSMENT, THE FOLLOWING ELEMENTS WERE ADDED TO ALIGN WITH CURRENT INVESTIGATION REQUIREMENTS: COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 11/MAR/2026 AGAINST LOT NUMBER 6000471 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE REVIEW CONFIRMED THAT LOT 6000471 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NON-CONFORMANCE REPORT (NCRS) OR CAPAS OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 11/MAR/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6000471" AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR - DETACHMENT / SIGNIFICANT WETNESS, LEAKAGE FROM CONNECTION BETWEEN THE TUBING CONNECTOR AND THE INFUSION SET (CANNULA PART/BASE PIECE), TUBING DETACHED FROM TUBING-TUBING CONNECTOR, TUBING CONNECTOR IS CRACKED, SPLIT, DEFORMED, LEAKAGE MAY OCCUR. THE NUMBER OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS COMPLAINT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000471 WAS MANUFACTURED ACCORDING TO WORK INSTRUCTION (WI) VERSION 75.0 AND MANUFACTURED IN THE M12, ON 31/MAR/2023 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY: LOT 3C05531 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 AND ASSEMBLED IN THE QUICKSET LINE, ON 29/MAR/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING: LOT 3C05543 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP08, ON 29/MAR/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3C05541 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE MP04, ON 29/MAR/2023, WITH A TOTAL OF (B)(4) UNITS. THE 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). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN POLAND. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED THE INFUSION SET TUBING DETACHMENT FROM THE QUICK RELEASE EVENT ON (B)(6) 2023. THE SITE LOCATION WAS THE ABDOMEN. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778375 QUICK SET UNO QUICK-SET 46/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-394A 6000471 05705244017337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown