BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO SAFELET IV CATHETER

    MDR report key: 17394148 · Received July 25, 2023

    Report

    Report Number
    1056186-2023-00006
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 19, 2023
    Report Date
    July 25, 2023
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    22 GAUGE IV CATHETER CANNULA WHICH WAS INSERTED INTO SAPHENOUS VEIN ON R FOOT BROKE DURING REMOVAL. BREAKAGE OF 3MM DISTAL TIP OF CANNULA ON AN UNSUCCESSFUL IV ATTEMPT, FOUND TIP OF PLASTIC CATHETER BROKEN OFF AND MISSING UPON REMOVAL OF IV. HIGHLY UNUSUAL FOR IT TO BREAK LIKE THIS AFTER USING THOUSANDS OF THE SAME CATHETERS. 3 MM CATHETER TIP SEEN ON FOOT X-RAY PT NEEDING FURTHER IMAGING, WORKUP, EXPLORATION AND SURGICAL REMOVAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813188 NIPRO SAFELET IV CATHETER CATHETER FOZ NIPRO CORPORATION (ODT) CI+2225-2C 22D04C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention