BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTACT DETACH

    MDR report key: 20244972 · Received September 18, 2024

    Report

    Report Number
    3003442380-2024-25634
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    May 18, 2024
    Report Date
    November 15, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    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, EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4, PMA/510(K) NUMBER UNDER G4. 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 DHR REVIEW, WHICH WAS NECESSARY TO ADVANCE THE PARENT RECORD TO THE REVIEW AND SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003270, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003270 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 AND PACKAGING IN THE MULTIVAC 10 ON 17/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3J01209 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 55 AND MANUFACTURED IN THE MACHINES SC05 & SC06 ON 14/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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: ONE NON-CONFORMANCE (NC) RAISED DURING STERILIZATION PROCESS UNRELATED TO COMPLAINT CODE, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET OCCLUSION IN TUBING. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448966 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6003270 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male