BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDI POVIDONE-IODINE SWABSTICKS

    MDR report key: 7352184 · Received March 20, 2018

    Report

    Report Number
    7352184
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 8, 2018
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSE PRACTITIONER WAS GOING TO USE POVIDONE-IODINE SWABSTICKS FOR SKIN ANTISEPTIC FOR AN UMBILICAL LINE PLACEMENT. THE SWAB WAS OPENED BY THE BEDSIDE NURSE TO HAND OFF IN A STERILE FASHION TO THE PROVIDER PLACING THE LINES. THE FIRST STICK WAS OPENED AND THE PROVIDER REMOVED IT FROM THE PACKAGE AND IT WAS DRY AND NEVER HAD IODINE ON IT. THIS PROCESS WAS REPEATED WITH 3 SEPARATE SWABS THAT WERE DRY WITHOUT IODINE. NO HARM TO PATIENT, BUT DELAYED THE PROCEDURE WHILE NURSE LOCATED SWABS WITH IODINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199061 PDI POVIDONE-IODINE SWABSTICKS APPLICATOR, ABSORBENT TIPPED, NON-STERILE KXF PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. L11701386

    Patients

    Seq Age Sex Outcome Treatment
    1