BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS

    MDR report key: 14601397 · Received June 6, 2022

    Report

    Report Number
    14601397
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 24, 2022
    Report Date
    May 31, 2022
    Manufacturer
    CAREFUSION 2200, INC
    Product Code
    PXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: PATIENT GETTING A PARACENTESIS AND THE KIT DID NOT HAVE THE 2 AMPULES OF LIDOCAINE AS LISTED IN CONTENTS. BACKGROUND: COVID POSITIVE PATIENT TO RECEIVE A PARACENTESIS AT THE BEDSIDE. ASSESSMENT: KIT MISSING CRITICAL COMPONENTS--LIDOCAINE. RECOMMENDATION: GOING FORWARD CHECK KITS--LOT# 0001461613 FOR AMPULES OF LIDOCAINE TO SEE IF ISSUE IS WIDESPREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413053 SAFE-T-CENTESIS THORACENTESIS TRAY PXI CAREFUSION 2200, INC PIG1260T 0001461613

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other