BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 22478906 · Received July 11, 2025

    Report

    Report Number
    1451040-2025-00047
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 16, 2025
    Report Date
    August 1, 2025
    Manufacturer
    SHINCHANG MEDICAL CO., LTD
    Product Code
    QOI
    UDI-DI
    10612479212593
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP UPDATES THE AWARENESS DATE F6.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT ON 5 OCCASIONS, CATHETERS LEAKED. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THE PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948637 MCKESSON BRANDS CATHETER, IV 24GX3/4" QOI SHINCHANG MEDICAL CO., LTD UNKNOWN 10612479212593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown