BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    MDR report key: 24616902 · Received March 17, 2026

    Report

    Report Number
    3010293992-2026-00017
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 23, 2026
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109150710
    PMA / PMN Number
    K161667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL HAS CONDUCTED ATTEMPTS TO RECEIVE THE EVENT LOG OF PUMP, AS WELL AS THE PUMP ITSELF, FOR INVESTIGATION. TO DATE, ONLY THE EVENT LOG HAS BEEN RECEIVED AND IS CURRENTLY UNDER INVESTIGATION. EVENT LOG INVESTIGATION FINDINGS WILL BE PROVIDED IN THE FOLLOW UP REPORT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K161667.

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP'S EVENT LOG. INVESTIGATION FINDINGS: NO INDICATION OF OVER DELIVERY WAS OBSERVED IN THE EVENT LOG INVESTIGATION. CONCLUSION: PER THE CURRENT INVESTIGATION, THERE IS NO INDICATION OF ANY IRREGULARITIES. EITAN MEDICAL HAS REQUESTED THE PUMP TO BE RECEIVED FOR INVESTIGATION. WHEN RECEIVED, THE PUMP WILL BE TESTED, AND THE TEST RESULTS WILL BE PRESENTED IN AN ADDITIONAL REPORT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K161667.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. REHOSPITALIZATION AND MEDICAL INTERVENTION (ADMINISTERED NALOXONE) WERE REPORTED IN THE EVENT. HOWEVER, NO HUMAN HARM, INCLUDING PERMANENT IMPAIRMENT, SERIOUS INJURY, OR DETERIORATION IN THE PATIENT'S STATE OF HEALTH BEYOND THE NEED FOR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. REHOSPITALIZATION AND MEDICAL INTERVENTION (ADMINISTERED NALOXONE) WERE REPORTED IN THE EVENT. HOWEVER, NO HUMAN HARM, INCLUDING PERMANENT IMPAIRMENT, SERIOUS INJURY, OR DETERIORATION IN THE PATIENT'S STATE OF HEALTH BEYOND THE NEED FOR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680082 SAPPHIRE M.T INFUSION PUMP - FRENCH INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109150710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R