BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER PLUS NEEDLES

    MDR report key: 22319507 · Received June 24, 2025

    Report

    Report Number
    3012307300-2025-07550
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 23, 2025
    Report Date
    October 17, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD OF REPORTED LOT NUMBER 6061434 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 SAMPLES A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    ONE (1) USED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND THE REPORTED ISSUE WAS DUPLICATED. TA LEAK WAS OBSERVED AT THE JUNCTION OF THE TUBING AND THE NEEDLE. PROBABLE CAUSE, INSUFFICIENT SOLVENT DURING ASSEMBLY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN FLUSHING THE PORT NEEDLE, FLUID LEAKED BETWEEN THE NEEDLE AND THE CONNECTING TUBE, AND THE NURSE IMMEDIATELY REPLACED THE PORT NEEDLE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390730 DELTEC GRIPPER PLUS NEEDLES SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6061434 10610586033001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male