BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 19544216 · Received June 15, 2024

    Report

    Report Number
    8021545-2024-01143
    Event Type
    Malfunction
    Date Received
    June 15, 2024
    Date of Event
    April 23, 2024
    Report Date
    November 21, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018723
    PMA / PMN Number
    K162812
    Product Problem
    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. REVISION 21 OF RECORD (B)(4) DOES NOT REQUIRE A TYPE 2 REPORTABLE COMPLAINT TO INITIATE A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS CREATED AND SUBSEQUENTLY CLOSED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW, WHICH WAS NECESSARY TO ADVANCE THE PARENT RECORD TO THE REVIEW AND SUMMARY. COMPLAINT INVESTIGATION: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003628 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003628 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 15 AND MANUFACTURED IN THE MACHINE MULTIVAC 10 ON 11/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. CANNULA LOT: THE LOT 3J04445 WAS MANUFACTURED ACCORDING TO THE WI 5277 VERSION 11 AND MANUFACTURED IN THE MACHINE LC05 ON 05/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J00983 WAS MANUFACTURED ACCORDING TO THE WI VERSION 11 AND MANUFACTURED IN THE MACHINE LC05 ON 13/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONE OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OCCLUSION ISSUE, AND OCCLUSION TROUBLESHOOTING INDICATED AN ISSUE WITH THE INFUSION SET SITE. THE PATIENT NOTICED SYMPTOMS 3 OR MORE HOURS AFTER INSERTION. THE SITE WAS INSERTED IN THE ABDOMEN. THE PATIENT REGULARLY ROTATES SITE LOCATIONS. THE SITE AREA WAS NOT IMPACTED IN ANY WAY. THE PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE PATIENT RESOLVED THE ISSUE BY CHANGING THE SOFT CANNULA INFUSION SET AND RESUMING INSULIN. 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
    327891 VARISOFT UNO COMFORT SHORT 80/13 TCAP 10PK INT FPA UNOMEDICAL A/S 1002828 6003628 05705244018723

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female