BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 23932827 · Received December 31, 2025

    Report

    Report Number
    3003442380-2025-18100
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    October 11, 2025
    Report Date
    February 6, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244005693
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 05-FEB-2026 AGAINST "LOT NUMBER 6013698 AND SIMILAR MALFUNCTION CODES: COMPONENT DEFECT- STEEL CANNULA OR STEEL INTRODUCER NEEDLE BREAKS IN INFUSION SITE, STEEL CANNULA FRACTURES DURING INSERTION INTO THE INFUSION SITE (BROKEN NEEDLE), INTRODUCER NEEDLE FRACTURES/BREAKS DURING INSERTION INTO THE INFUSION SITE, INTRODUCER NEEDLE FOUND FRACTURED/BROKEN UPON REMOVAL FROM INFUSION SITE AFTER NORMAL USE. THE REVIEW CONFIRMED THAT LOT 6013698 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 05-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL 6013698 AND SIMILAR MALFUNCTION CODES COMPONENT DEFECT- STEEL CANNULA OR STEEL INTRODUCER NEEDLE BREAKS IN INFUSION SITE, STEEL CANNULA FRACTURES DURING INSERTION INTO THE INFUSION SITE (BROKEN NEEDLE), INTRODUCER NEEDLE FRACTURES/BREAKS DURING INSERTION INTO THE INFUSION SITE, INTRODUCER NEEDLE FOUND FRACTURED/BROKEN UPON REMOVAL FROM INFUSION SITE AFTER NORMAL USE. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013698 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND MANUFACTURED IN THE MULTIVAC 14, ON 01-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY WELDING LOT 5E04027 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE LS24 AND LS25, ON 03-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY WELDING LOT 5E04007 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED IN THE MACHINE LS06 AND LS07, ON 02-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY GLUING OF CONNECTOR LOT 5E02171 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 03, ON 03-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY GLUING OF CONNECTOR LOT 5E02170 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 03, ON 02-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY GLUING OF CONNECTOR LOT 5E02172 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 03, ON 03-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY GLUING OF CONNECTOR LOT 5E02173 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 AND MANUFACTURED IN THE LINE 03, ON 04-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY MOLDING OF THE LOT 5E00649 WAS MANUFACTURED ACCORDING TO THE WI VERSION 36 AND MANUFACTURED IN THE GLUING MOLDER LS18, ON 02-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY MOLDING OF THE LOT 5E00639 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MOLDER LS14, ON 02-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY MOLDING OF THE LOT 5E03967 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MOLDER LS19, ON 03-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY MOLDING OF THE LOT 5E03966 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MOLDER LS19, ON 31-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY MOLDING OF THE LOT 5E00647 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MOLDER LS18, ON 31-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. TEST 6 IN CONTAMINATION LOOSE, EXTENDED SAMPLING PLAN ACCEPTABLE. 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 1 STATIC PULL TEST FOR COMPLAINTS AREA VERSION 2: ALL 3 SAMPLES TESTED PASSED FUNCTIONAL TESTING. MALFUNCTION CODE COMPONENT DEFECT- STEEL CANNULA OR STEEL INTRODUCER NEEDLE BREAKS IN INFUSION SITE. 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: 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). 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 6013698 AND RELATED MALFUNCTION CODES. ONE COMPLAINT WAS 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. SAMPLES WERE REQUESTED; HOWEVER, THE CUSTOMER CONFIRMED THAT NO SAMPLES WERE AVAILABLE FOR ANALYSIS. CONSEQUENTLY, AN INVESTIGATION WAS CONDUCTED USING REFERENCE SAMPLES, AND NO FAILURES RELATED TO THE COMPLAINT WERE IDENTIFIED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION AND REFERENCE SAMPLE ANALYSIS ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO STEEL NEEDLE DETACH FROM THE INFUSION SET AND EMBEDDED IN THE ARM. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189104 CONTACT DETACH UNO CONTACT DETACH G29 60/6 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-863 6013698 05705244005693

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| H