BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION IV STABILIZATION KIT WITH PI EXTENSION

    MDR report key: 19690829 · Received July 5, 2024

    Report

    Report Number
    MW5157081
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 2, 2024
    Manufacturer
    CENTURION MEDICAL PRODUCTS LP
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE IV EXTENSION LINE WITH THE IV STABILIZATION KIT MALFUNCTIONED IN A WAY THAT IT DOES NOT FLUSH SALINE; SUCH AS A BLOCKED IV LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459400 CENTURION IV STABILIZATION KIT WITH PI EXTENSION I.V. START KIT LRS CENTURION MEDICAL PRODUCTS LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown