BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURAPLEX

    MDR report key: 23193551 · Received October 1, 2025

    Report

    Report Number
    3003674698-2025-01094
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 1, 2025
    Manufacturer
    MEDSOURCE LABS LLC
    Product Code
    FOZ
    PMA / PMN Number
    K150611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE HUB BROKE OFF WHEN A PATIENT WAS BEING TREATED BY PARAMEDICS, THE HUB BROKE OFF ONCE THE NEEDLE WAS INSIDE THE PATIENT. IT WAS NOT ABLE TO BE PULLED OUT, THE PATIENT WILL NEED A PROCEDURE TO REMOVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795643 CURAPLEX CURAPLEX IV CATHETER CURASLIDE 18G FOZ MEDSOURCE LABS LLC 1612-84130 31262/0761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O| R