BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER PLUS NEEDLES

    MDR report key: 22726201 · Received August 6, 2025

    Report

    Report Number
    3012307300-2025-09342
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 6, 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: NEITHER SAMPLES NOR PICTURES WERE 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 USED SAMPLES 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 REPORTED THAT THE PATIENT EXPERIENCED ERYTHEMA AND TISSUE SWELLING AFTER THE DEVICE WAS IMPLANTED. THE REPORTER NOTED THAT THE PATIENT WAS FOUND WITH A SWOLLEN AREA OF ABOUT 20.0*18.0CM IN THE RIGHT LOWER ABDOMEN. AFTER REMOVING THE TRANSPARENT FILM, THE NURSE FOUND THAT HALF OF THE INDWELLING NEEDLE WAS EXPOSED. LIGHT BLOODY FLUID WAS SEEN IN THE WITHDRAWN FLUID, SO THE NURSE IMMEDIATELY REPORTED IT TO THE DOCTOR. THE DOCTOR REMOVED THE INDWELLING NEEDLE AND PERFORMED AN ULTRASOUND EXAMINATION ON THE PATIENT. THE RESPONSIBLE NURSE DISINFECTED IT AGAIN, REPLACED IT WITH AN IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM OF ANOTHER SPECIFICATION, AND FLUSHED THE TUBE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364847 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 79 YR Male