BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL PROCEDURE TRAY

    MDR report key: 24078787 · Received January 15, 2026

    Report

    Report Number
    24078787
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 13, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    OWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STERILE T CONNECTOR ON PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE NOTED TO BE CRACKED AND LEAKING. NNP [NEONATAL NURSE PRACTITIONER] AT BEDSIDE AT THE TIME AND DECISION MADE WITH NNP AND MD TO REMOVE STERILE T CONNECTOR NOW AND WILL REPLACE NEW ONE STERILELY WITH TPN [TOTAL PARENTERAL NUTRITION] FLUID CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140175 NEONATAL PROCEDURE TRAY PERIPHERAL CATHETER INSERTION KIT OWL ARGON MEDICAL DEVICES, INC. 384835 11603440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown