BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET

    MDR report key: 21594641 · Received March 13, 2025

    Report

    Report Number
    3003442380-2025-03704
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 3, 2025
    Report Date
    April 22, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244025202
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 THE INFORMATION IN THIS COMPLAINT 2140015 HAS BEEN EVALUATED. THE BATCH 6006635 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE INSERTION WITHOUT REMOVING NEEDLE GUARD. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS VISUAL TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6006635 WAS MANUFACTURED ACCORDING TO THE WI VERSION 112 AND MANUFACTURED IN THE LINE 6, ON 21/APR/2024, WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 25/MAR/2025 AGAINST MALFUNCTION CODE INSERTION WITHOUT REMOVING NEEDLE GUARD AND LOT 6006635 AND OTHER NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6006635 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ANOTHER 1 COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE. NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT WHERE THE PATIENT FORGOT TO REMOVE NEEDLE GUARD ON (B)(6) 2025 RESULTING IN PAIN AT INFUSION SITE. 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
    1700707 INSET UNO INSET I 60/6 GREY BETA 10PK INT FPA UNOMEDICAL UM-D FG000016-01 6006635 05705244025202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown