BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC LUERACTIVE Y-SITE GRIPPER PLUS

    MDR report key: 21890783 · Received April 23, 2025

    Report

    Report Number
    3012307300-2025-04670
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    December 1, 2024
    Report Date
    April 23, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586025570
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2025-00150-00. THE DATE OF THAT SUBMISSION WAS 20-FEB-2025. B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. INVESTIGATION SUMMARY: RECEIVED ONE (1) USED. LIST #21-2961-24, NDL, GRIPPER PLUS, 22G X .75" (19MM), NEEDLELESS Y-SITE. AS RECEIVED NO DAMAGE OR ANOMALIES WERE OBSERVED. IN ATTEMPTS TO REPLICATE CLINICAL USE THE FEMALE LUER WAS ACCESSED WITH A SYRINGE WITH BLACK DYE PROVIDED BY ICU MEDICAL. IT WAS OBSERVED THAT DYE WOULD NOT MAKE IT INTO THE Y-SITE. UPON FURTHER INSPECTION ERRANT SOLVENT WAS OBSERVED AT THE TUBE Y-SITE BOND. THE COMPLAINT OF NO FLOW CAN BE CONFIRMED. THE PROBABLE CAUSE IS DUE TO ERRANT SOLVENT APPLICATION DURING MANUFACTURING IN TIJUANA. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE CLAMP WAS OPENED AND THE OPERATOR OF THE DEVICE TRIED TO FLOW THE CHEMICAL SOLUTION, THE SOLUTION DID NOT FLOW. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560302 DELTEC LUERACTIVE Y-SITE GRIPPER PLUS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6006094 10610586025570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown