BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL PROCEDURE TRAY

    MDR report key: 8270366 · Received January 23, 2019

    Report

    Report Number
    8270366
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    November 29, 2018
    Report Date
    December 11, 2018
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    OWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEONATAL NURSE PRACTITIONER WENT TO PLACE A PICC ON A PATIENT IN NICU. UPON SETTING UP THE STERILE FIELD AND OPENING THE NEONATAL PROCEDURE TRAY PICC CATHETERS FOR PLACEMENT OF NEONATAL FROM ARGON MEDICAL DEVICES, INC., SHE NOTICED CONTAMINANT ON THE STERILE INSTRUMENTS. SHE IMMEDIATELY STOPPED THE PROCESS OF SETTING UP THE STERILE FIELD. THE PACKAGING AND INSTRUMENTS WERE PULLED FROM THE FIELD. NICU HAD THE CONTAMINANT TESTED AND FOUND OUT THAT IT WAS BIOBURDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64679 NEONATAL PROCEDURE TRAY PERIPHERAL CATHETER INSERTION KIT OWL ARGON MEDICAL DEVICES, INC. 384835 11221241

    Patients

    Seq Age Sex Outcome Treatment
    1