BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 25054135 · Received May 1, 2026

    Report

    Report Number
    3003442380-2026-13243
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 10, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STREET: 11045 ROSELLE STREET. COUNTRY: UNITED STATES OF AMERICA. CITY: SAN DIEGO. STATE: CALIFORNIA. ZIP CODE: 92121. 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 28-APR-2026 AGAINST LOT NUMBER 6011596 AND SIMILAR MALFUNCTION CODES: STEEL CANNULA IS FOUND BENT UPON REMOVAL FROM INFUSION SITE - BLOCKAGE, STEEL CANNULA IS FOUND BENT UPON REMOVAL FROM INFUSION SITE. THE REVIEW CONFIRMED THAT LOT 6011596 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 28-APR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6011596 AND SIMILAR MALFUNCTION CODES: STEEL CANNULA IS FOUND BENT UPON REMOVAL FROM INFUSION SITE - BLOCKAGE, STEEL CANNULA IS FOUND BENT UPON REMOVAL FROM INFUSION SITE. THE COUNT OF COMPLAINTS IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011596 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100 AND PACKAGING IN THE MACHINE MULTIVAC 14, ON 08-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. WELDING - THE LOT 5A04044 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE L506 & L507, ON 03-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. WELDING - THE LOT 5A04041 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE L506 & L507, ON 01-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. GLUING CONNECTOR - THE LOT 5A04009 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 03-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. GLUING CONNECTOR - THE LOT 5A04011 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 05-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. GLUING CONNECTOR - THE LOT 5A04007 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 01-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. GLUING CONNECTOR - THE LOT 5A04008 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 01-FEB-2025 WITH A TOTAL OF (B)(4) UNITS. GLUING CONNECTOR - THE LOT 5A04004 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 03-FEB-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 SAMPLES TESTED PASSED VISUAL INSPECTION. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA (VERSION 2): ALL SAMPLES TESTED PASSED FUNCTIONAL FLOW AND LEAK TESTS FOR THE REPORTED MALFUNCTION CODE STEEL CANNULA IS FOUND BENT UPON REMOVAL FROM INFUSION SITE - BLOCKAGE ALL TEST RESULTS WERE WITHIN SPECIFICATION AS DOCUMENTED IN THE ATTACHED TEST REPORT COMPLAINT (B)(4) TEST REPORT. CONCLUSION: TESTING DID NOT CONFIRM THE REPORTED ISSUE; NO NONCONFORMANCE IDENTIFIED. 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 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. 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, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6011596 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WERE IDENTIFIED FOR THIS LOT; HOWEVER, NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. BASED ON THE DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. 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 SERIOUS INJURY. 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 THE PATIENT WAS INITIALLY ADMITTED TO INTENSIVE CARE UNIT FOR TWENTY-FOUR HOURS WITH HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS ON (B)(6) 2026 DUE TO KINKED NEEDLE. THE PATIENT EXPERIENCED SYMPTOMS OF VOMITING AND NAUSEA AND THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN INFUSION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER SPENDING SIX DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135078 CONTACT DETACH SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 1002833 6011596 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male