BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23739165 · Received December 8, 2025

    Report

    Report Number
    3003442380-2025-17191
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 25, 2025
    Report Date
    January 31, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-17191), WAS SUBMITTED ON 08-DEC-2025. UPON RECEIVING ADDITIONAL INFORMATION, IT WAS DISCOVERED THE EVENT DATE HAS BEEN CHANGED. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: B3: DATE OF EVENT 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 (B)(6) 2025 AGAINST "LOT NUMBER 6013471 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - REDUCED FLOW, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, SOFT CANNULA BENT (NO HARM). THE REVIEW CONFIRMED THAT LOT 6013471 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON (B)(6) 2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013471 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL REDUCED FLOW, SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL BLOCKAGE. THE COUNT OF COMPLAINT IS 3. THE COMPLAINT NUMBERS ARE COMPLAINT (B)(4). ESCALATE TO CAPA DETERMINATION FOR STATISTICAL ANALYSIS. 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 (B)(6) 2025, WITH A TOTAL OF (INSERT BATCH QUANTITY) 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. THE SUB-ASSEMBLY: THE LOT 5E03513 WAS ASSEMBLED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED ON 25-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E04122 WAS ASSEMBLED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED ON 26-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E03514 WAS ASSEMBLED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED ON 25-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E04123 WAS ASSEMBLED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED ON 26-MAY-2025, WITH A TOTAL OF 29,213 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. GLUING OF TUBING OF THE LOT 5E03432 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08, ON (B)(6) 2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5E03433 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08, ON (B)(6) 2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5E03435 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08, ON (B)(6) 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. RETAIN SAMPLES TESTING: RETAIN SAMPLES FROM THE RELEVANT LOT WERE REQUESTED AND TESTED IN ACCORDANCE WITH APPROVED PROCEDURES: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: ALL 3 SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING FOR THE REPORTED MALFUNCTION CODE SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4). THE REFERENCE SAMPLES HAVE BEEN TESTED ON (B)(6) 2025. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE ABOVE INVESTIGATION, FURTHER INVESTIGATION IS REQUIRED BECAUSE THE FOLLOWING THRESHOLD WAS MET 3 OR MORE COMPLAINTS EXIST FOR THE SAME LOT AND SIMILAR MALFUNCTIONS. A CHILD INVESTIGATION HAS BEEN OPENED COMPLAINT (B)(4). STATISTICAL ANALYSIS RESULT: AFTER ASSESSMENT OF THE FAILURE VIA PRODUCT TRENDING OVER TIME FORM SIGNED, WITH CONTROL CHARTS, THE RISK HAS BEEN DEEMED AS WITHIN ACCEPTED LIMITS. NO FURTHER ACTION IS REQUIRED. COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORT FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. 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 SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL -BLOCKAGE MORE THAN 3 COMPLAINTS WERE IDENTIFIED FOR THIS LOT AND BASED ON THE ASSESSMENT OF THE MALFUNCTION AND PRODUCT FAMILY TRENDING OVER TIME, THE RISK HAS BEEN DEEMED WITHIN ACCEPTED LEVEL. 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.

    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 STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET BENT CANNULA EVENT ON 26-NOV-2025. THE INFUSION SET WAS IN USE FOR 1 DAY. THE PATIENT VISITED EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) 2025 DUE TO HIGH BLOOD GLUCOSE LEVEL. THE BLOOD GLUCOSE LEVEL WAS 415MG/DL. THE LENGTH OF HOSPITALIZATION WAS LESS THAN 24 HOURS. THE PATIENT ALSO EXPERIENCED SYMPTOMS OF FEELING SICK, UNWELL. THE PATIENT GOT TREATED WITH INTRAVENOUS DRIP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141212 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 Required Intervention