BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 25342632 · Received May 31, 2026

    Report

    Report Number
    3003442380-2026-24268
    Event Type
    Malfunction
    Date Received
    May 31, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 2, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). IMDRF CAUSE INVESTIGATION CODE: CODE B24 IS NOT AVAILABLE IN DATABASE TO CAPTURE EVENT HISTORY LOG REVIEW. 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 27/MAY/2026 AGAINST "LOT NUMBER" 6013750 AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AFTER DIRECT APPLICATION. ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AT POINT OF APPLICATION (I.E., NOT STICKY, NO ATTACHMENT, OR A FEW MINUTES OF ATTACHMENT). REFER TO IF THE ADHESIVE PATCH LIFTS DURING USE. THE REVIEW CONFIRMED THAT LOT 6013750 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 27/MAY/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013750 AND SIMILAR MALFUNCTION CODES: ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AFTER DIRECT APPLICATION. ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AT POINT OF APPLICATION (I.E., NOT STICKY, NO ATTACHMENT, OR A FEW MINUTES OF ATTACHMENT). REFER TO IF THE ADHESIVE PATCH LIFTS DURING USE. THE NUMBER OF COMPLAINTS IS 4. THE COMPLAINT NUMBER IS (B)(4). ESCALATE TO CAPA DETERMINATION FOR STATISTICAL ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT NUMBER 6013750 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12, ON 09-JUN-2025, WITH A TOTAL OF (B)(4). SUB-ASSEMBLY: ASSEMBLY LOT 5F01511 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI)VERSION 30 AND ASSEMBLED IN THE QUICKSET LINE, ON 09-JUN-2025, WITH A TOTAL OF (B)(4). LOT 5F01512 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 30 AND ASSEMBLED IN THE QUICKSET LINE, ON 09-JUN-2025, WITH A TOTAL OF (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT ALL REQUIRED IN PROCESS INSPECTIONS AND FINAL PRODUCT TESTS WERE COMPLETED. DURING OUTGOING TEST NO. 9, AN EXTENDED CONDITION DUE TO DELAMINATION; HOWEVER, EXTENDED SAMPLING WAS PERFORMED IN ACCORDANCE WITH ESTABLISHED PROCEDURES, AND THE RESULTS MET THE SPECIFIED ACCEPTANCE CRITERIA. NO DEVIATIONS, NONCONFORMANCES, OR EQUIPMENT RELATED MAINTENANCE EVENTS WERE IDENTIFIED THAT CORRELATE WITH THE REPORTED COMPLAINT CONDITION. CONCLUSION: THE DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS. THE ISOLATED OUTGOING TEST 9 FINDING WAS APPROPRIATELY ADDRESSED THROUGH EXTENDED SAMPLING WITH ACCEPTABLE RESULTS. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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 MALFUNCTION(S). THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS A RECURRING OR SYSTEMIC ISSUE 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. 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 NUMBER 6013750 AND RELATED MALFUNCTION CODES FOR ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AFTER DIRECT APPLICATION. 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. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545. MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT FACED INFUSION SET TAPE NOT STICKING ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214811 QUICK SET SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V MMT-399A 6013750 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1