BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP® INSET

    MDR report key: 19727875 · Received July 12, 2024

    Report

    Report Number
    3003442380-2024-13757
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 12, 2024
    Report Date
    October 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1910571- MDR 3003442380-2024-13757 - DEVICE 1 OF 5

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-13757. 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 (B)(4) HAS BEEN EVALUATED. THE BATCH 6003174 IN QUESTION WAS MANUFACTURED AT REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION GUIDELINES FOR TEST OF REFERENCE SAMPLES BUID-UMD VERSION 11 FOR THE CODE ADHESIVE PATCH LIFTS OR DETACHES DURING USE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WERE NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WORK INSTRUCTION VERSION 18 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: - THE LOT 6003174 WAS MANUFACTURED ACCORDING TO THE DOCUMENT (B)(4) VERSION 63 ON THE INSET 6, ON 05/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 PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. A QUERY WAS RUN IN TRACKWISE AGAINST MALFUNCTION CODE ADHESIVE PATCH LIFTS OR DETACHES DURING USE AND LOT 6003174 AND NO OTHER ONE COMPLAINT HAS BEEN REGISTERED IN TRACKWISE SINCE THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVELLIENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6) THE PATIENT REPORTED THAT FIVE CATHETERS WERE DISPOSED AS THE PLASTER CAME OFF WITHIN ONE DAY OF USE ON (B)(6)/2024. THE WEARING POSITION WAS LEG AND BACK. DURATION OF USE WAS 1-2 DAYS. 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
    272198 YPSOPUMP® INSET UNO INSET II 60/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-060-52B6 6003174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose