BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP® INSET

    MDR report key: 20526477 · Received October 24, 2024

    Report

    Report Number
    3003442380-2024-28661
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    August 26, 2024
    Report Date
    November 26, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4). DEVICE 2 OF 5. E1: PATIENT COUNTRY: GERMANY SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. 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.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-28661. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H11: INVESTIGATION SUMMARY H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION. THE INFORMATION IN THIS COMPLAINT PR.2021894 HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REF. SAMPLES VERSION 11 FOR THE CODE PRIMARY PACK HAS INCOMPLETE OR OPEN SEAL/WELD, IS TORN, RIPPED, CONTAINS HOLES, EXHIBITS EXTERNAL CONTAMINATION (E.G., WATER MARKS, STAINS) OR PRODUCT IS TRAPPED IN PACKAGING (E.G. TRAPPED IN WELD). COMPLAINT INVESTIGATIONS. 1 PHOTO WAS PROVIDED. THE FOLLOWING TESTS WERE PERFORMED: VISUAL INSPECTION ACCORDING TO WITH VERSION 18, IS UNABLE TO CONFIRM IF THERE IS A LACK OF SEAL FOR THE TYVEK ON THE OUTER RING. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE INFORMATION OF THIS COMPLAINT HAS BEEN EVALUATED. SINCE NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION ON BATCH REVIEW CANNOT BE CONDUCTED. AS A RESULT OF THE FOLLOWING: NO REPORTED HARM, NO LOT NUMBER IS AVAILABLE. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD HAVE FLAGGED ON THE TRIPS AND ALERTS ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY ON (B)(6) 2024, PATIENT REPORTED THAT 5 INFUSION SETS WAS NOT SEALED. 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
    2565114 YPSOPUMP® INSET UNO INSET II 46/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-060-52B6 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown