BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVANTICS

    MDR report key: 7159779 · Received January 3, 2018

    Report

    Report Number
    7159779
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    September 15, 2017
    Report Date
    December 8, 2017
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CONFUSING AND SIMILAR PACKAGING UPON OPENING THE LENS CLEANING WIPE (THINKING IT WAS A PREVANTICS CHLORHEXIDINE GLUCONATE SWAB, I NOTICED A DIFFERENT TEXTURE TO THE WIPE THAN WHAT IS TYPICAL FOR THE PREVENTICS SWAB AND DID NOT USE IT ON THE IV PORT. THIS IS LIKELY TO CAUSE AN ERROR WITH THIS PACKAGING SIMILARITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4393 PREVANTICS PAD, ALCOHOL, DEVICE DISINFECTANT LKB PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1