BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRAXIJECT SP 0.9% NACL

    MDR report key: 20999735 · Received December 23, 2024

    Report

    Report Number
    20999735
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 3, 2024
    Report Date
    December 9, 2024
    Manufacturer
    MEDXL INC
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MULTIPLE ACCOUNTS OF 10CC PREFILLED NS FLUSH PRAXIJECT SP 0.9% NACL, REF 3705-3, LOT 24E0454 PLUNGER BREAKS WITH PRESSURE. BROKEN EQUIPMENT RETAINED IF DESIRED. NO HARM TO STAFF OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625960 PRAXIJECT SP 0.9% NACL SALINE, VASCULAR ACCESS FLUSH NGT MEDXL INC 3705-3 24E0454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose