BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER PLUS NEEDLES

    MDR report key: 23063825 · Received September 16, 2025

    Report

    Report Number
    3012307300-2025-10697
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 16, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586033001
    PMA / PMN Number
    K072657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO PRODUCT WAS RECEIVED FOR ANALYSIS. THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 6061435 WAS REVIEWED, AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. WITHOUT THE RETURN OF THE PRODUCT A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS STATED IN THE REPORT THAT IT WAS DIFFICULT TO DRAW BLOOD BACK AND PUSH FLUID AFTER THE PORT NEEDLE WAS INSERTED INTO THE INFUSION PORT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2621442 DELTEC GRIPPER PLUS NEEDLES SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6061435 10610586033001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown