BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 22669426 · Received July 30, 2025

    Report

    Report Number
    3003674698-2025-01033
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 30, 2025
    Manufacturer
    MEDSOURCE LABS LLC.
    Product Code
    FOZ
    UDI-DI
    00810094574185
    PMA / PMN Number
    K223788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE NEEDLE WAS STILL INSIDE THE CATHETER AFTER HITTING THE NEEDLE RETRACT BUTTON. THE CATHETER WAS INSIDE OF THE PATIENT'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56055 CURAPLEX CURASLIDE BC IV CATHETER 20G FOZ MEDSOURCE LABS LLC. 1613-86220 40758/0456 00810094574185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O