BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 22960820 · Received September 4, 2025

    Report

    Report Number
    3003442380-2025-13369
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    July 5, 2025
    Report Date
    January 18, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION CAPA/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS SUPPLEMENTAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. MEDICAL DEVICE REPORT (MDR) RETRACTION: THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-13369), WAS SUBMITTED ON 04-SEP-2025. HOWEVER, BASED ON THE INVESTIGATION DONE ON 18-JAN-2026 AND CLINICAL REVIEW PERFORMED ON 23-JAN-2026, IT WAS FOUND THAT THE SERIOUS INJURY WAS NOT RELATED TO INFUSION SET AND THERE IS NO ALLEGATION ON THE INFUSION SET. NOW, THIS CASE HAS BEEN DETERMINED TO BE NON-REPORTABLE. HENCE, THIS MDR IS BEING SUBMITTED TO RETRACT THE INITIAL MDR. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: ISRAEL. H11: 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 ISRAEL. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF HIGH BLOOD GLUCOSE ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 480 MG/DL. THEREFORE, THE PATIENT WAS HOSPITALIZED FOR TWENTY-FOUR HOURS. DURING HOSPITALIZATION, THE PATIENT WAS TREATED BY INSULIN INTRAVENOUSLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233663 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A UNKNOWN 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H