BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC GRIPPER PLUS

    MDR report key: 20301361 · Received September 25, 2024

    Report

    Report Number
    9617604-2024-00756
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    July 30, 2024
    Report Date
    April 10, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586027697
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: RECEIVED ONE (1) USED. LIST #21-2961-24, NDL, GRIPPER PLUS, 22G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; LOT #4463747. AS RECEIVED, NOTICED THE TUBING PARTIALLY SEPARATED FROM THE Y JUNCTION. NO OTHER DAMAGE OR ANOMALIES OBSERVED. ONE (1) PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER SHOWING THE LOCATION OF THE LEAK. CONFIRMED COMPLAINT OF BROKEN TUBING, PROBABLE CAUSE, EXCESS SOLVENT AND UNINTENTIONAL BENDING FORCE. 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.

    Additional Manufacturer Narrative · 0

    NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. FUNCTIONAL AND VISUAL TESTING COULD NOT BE PERFORMED AND NO CONFIRMATION DUE TO NO DEVICE RETURNED. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED. THE DEVICE HISTORY REVIEW OF THE REPORTED LOT NUMBER FOUND NO NON-CONFORMITIES DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE CLEANING OF THE DEVICE WITH SALINE, THE NURSE NOTICED A LEAK AT THE Y-SITE. THE PLASTIC TUBE APPEARS TO BE BROKEN ON HALF OF THE DIAMETER OF THE RIGID PLASTIC BASE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198179 DELTEC GRIPPER PLUS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4463747 10610586027697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown