BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 19871255 · Received July 31, 2024

    Report

    Report Number
    1451040-2024-00038
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 31, 2024
    Manufacturer
    SHINCHANG MEDICAL CO., LTD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE SEPARATED FROM THE CATHETER HUB. WHEN THE HUB WAS PULLED AFTER SUCCESSFUL INSERTION, THE NEEDLE STAYED IN THE SHEATH. THERE WAS ENOUGH OF THE NEEDLE STICKING OUT TO BE REMOVED WITH THE USE OF TWEEZERS. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885017 MCKESSON BRANDS CATHETER, IV 20GX1" FOZ SHINCHANG MEDICAL CO., LTD KSL2203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown