BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN IDD

    MDR report key: 20553577 · Received October 28, 2024

    Report

    Report Number
    3003442380-2024-29494
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 17, 2024
    Report Date
    December 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    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: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY THE INFORMATION IN THIS COMPLAINT 2023497 HAS BEEN EVALUATED AS A SEVERITY 5 CASE. THE LOT 6005708 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH[?]WORK INSTRUCTION GUIDELINE FOR TEST OF REFERENCE SAMPLES BUID-UMD VERSION 11 FOR THE CODE "OCCLUSION AT INFUSION SITE (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED)" COMPLAINT INVESTIGATIONS: THE FOLLOWING TEST WAS PERFORMED: 4 USED SETS WAS PROVIDED AND IS FOUND PRODUCT IN ACCORDANCE WITH SPECIFICATIONS. - VISUAL TEST ACCORDING TO WITH VERSION 17, 4 RETURNED SETS PASSED THE TEST. - FUNCTIONAL TEST (FLOW). - ACCORDING TO WITH VERSION 9, 3 OUT 4 SETS WERE FOUND WITH INTRODUCER NEEDLE CLOGGED. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: - THE 6005708 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 14 ON THE PACKING PROCESS IN MULTIVAC 09 ON 17-FEB-2024 WITH 30,000 UNITS REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. A QUERY WAS RUN IN "OCCLUSION AT INFUSION SITE (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED)" AND LOT 6005708 AND 1 OTHER COMPLAINT HAS BEEN REGISTERED IN TRACKWISE SINCE THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON RETURNED SAMPLES, THREE SETS IS FOUND WITH INTRODUCER NEEDLE CLOGGED, FAILURE FOUND IS NOT RELATED TO MANUFACTURING PROCESS, NO REPORTED HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, OTHER ONE COMPLAINT HAS BEEN REGISTERED IN TRACKWISE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Additional Manufacturer Narrative · 0

    SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    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. IT WAS REPORTED THAT, THE PATIENT EXPERIENCED INSULIN FLOW BLOCK ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS LOCATED AT SITE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339199 INFUSION DEVICES - UNKNOWN IDD INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN IDD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female