BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24260515 · Received February 4, 2026

    Report

    Report Number
    3003442380-2026-00169
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 10, 2026
    Report Date
    February 4, 2026
    Manufacturer
    UNOMEDICAL UM-D
    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

    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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 04-FEB-2026 AGAINST "LOT NUMBER 6011624 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE, THE REVIEW CONFIRMED THAT LOT 6011624 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 10-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6011624 AND SIMILAR MALFUNCTION CODES: SOFT CANNULA BENT/KINKED/CRIMPED AFTER REMOVAL - BLOCKAGE, SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, SOFT CANNULA AND INTRODUCER NEEDLE FOUND BENT/KINKED DURING INSERTION, UNABLE TO USE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE. THE COUNT OF COMPLAINT IS 18. SEE ATTACHMENT LOT 6011624 QUICK SET FOR SIMILAR COMPLAINTS. ESCALATE TO CAPA DETERMINATION FOR STATISTICAL ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011624 WAS PACKAGING ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82, IN THE MACHINE MULTIVAC 12, ON 12-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 5B00455 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 11-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B00456 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 12-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B01777 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 09-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. SUB ASSEMBLY: GLUING TUBING: THE LOT 5B00438 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42, MANUFACTURED IN THE MACHINE 04-08, ON 08-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING TUBING: THE LOT 5B00439 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42, MANUFACTURED IN THE MACHINE 04-08, ON 11-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING TUBING: THE LOT 5B01648 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42, MANUFACTURED IN THE MACHINE 04, ON 08-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE DHR REVIEW INDICATED THAT DURING OUTGOING TEST 9, ONE SAMPLE WAS FOUND WITH NEEDLE BENT. DUE TO THE ORDER QUANTITY, A SAMPLING PLAN WAS NOT NECESSARY, THE BATCH WAS RELEASED. THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW IDENTIFIED MINOR FINDING. IT WAS MANAGED ACCORDING TO PROCEDURE AND DID NOT IMPACT COMPLIANCE; 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: THE REFERENCE SAMPLES FOR THE LOT 6011624 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION AND TESTED FOR FLOW IN THE DATABASE COMPLAINT (B)(4) ON 01-OCT-2025. ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4). CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: RETURN SAMPLES TESTING: RETURNED SAMPLES FROM THE RELEVANT LOT WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. CONCLUSION: VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO LACK OF SAMPLE AVAILABILITY. ASSESSMENT WILL BE BASED ON OTHER AVAILABLE EVIDENCE. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE ABOVE INVESTIGATION, FURTHER INVESTIGATION WAS REQUIRED BECAUSE THE FOLLOWING THRESHOLD WAS MET 3 OR MORE COMPLAINTS EXIST FOR THE SAME LOT AND SIMILAR MALFUNCTIONS. STATISTICAL ANALYSIS RESULT: AFTER ASSESSMENT OF THE FAILURE VIA PRODUCT TRENDING OVER TIME WITH CONTROL CHARTS, THE RISK HAS BEEN DEEMED AS WITHIN ACCEPTED LIMITS. NO FURTHER ACTION IS REQUIRED. SEE ATTACHMENT: FORM (MMT-397A) SIGNED, 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 6011624 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 WENT TO THE EMERGENCY ROOM (ER) AND WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) 2026 DUE TO A BENT CANNULA ON (B)(6) 2026, WHICH LED TO HYPERGLYCEMIA. SYMPTOMS INCLUDED CONFUSION, HEADACHE, WEAKNESS, INCREASED THIRST, AND FEELING UNWELL. THE EVENT OCCURRED ON THE FIRST DAY AFTER INSERTION. KETONES WERE PRESENT AT ELEVATED BORDERLINE LEVELS, APPROACHING DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN, WHICH RESOLVED THE ISSUE. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE LENGTH OF HOSPITAL STAY WAS LESS THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321744 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-397A 6011624 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention