BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CATHETER INSERTION KIT

    MDR report key: 12827617 · Received November 17, 2021

    Report

    Report Number
    12827617
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    November 11, 2021
    Report Date
    November 12, 2021
    Manufacturer
    VYGON CORPORATION
    Product Code
    OWL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NURSE (RN) NOTED THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) SITE DRESSING WAS QUESTIONABLY WET. PICC RN CALLED TO BEDSIDE TO ASSESS SITE. PICC RN ASSURED RN PICC SITE LOOKED OKAY AND DID NOT THINK THE SITE WAS WET. PATIENT'S RN STILL CONCERNED ABOUT SITE DUE TO PATIENT BEHAVIOR SUGGESTING THERE MAY BE A CONCERN. RN CALLED NEONATAL NURSE (NNP) AND REQUESTED TO ASSESS SITE. NNP CAME TO BEDSIDE AND FLUSHED THE SITE AND STATED THAT IS FLUSHED OKAY. NNP WAS REDRESSING THE SITE WHEN SHE THEN NOTICED SOME LEAKING AROUND THE SITE. WHEN THE NNP FLUSHED THE SITE AGAIN, THE FLUSH SQUIRT OUT OF THE SIDE OF THE PICC, SUGGESTING SOMETHING WAS WRONG WITH THE PICC. PICC DISCONTINUED. PIV PLACED TO MAINTAIN FLUIDS AND DROPS PER MINUTE (GTTS) FOR INFANT UNTIL NNP COULD RETURN TO PLACE ANOTHER PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730733 PERIPHERAL CATHETER INSERTION KIT OWL VYGON CORPORATION 21E018D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown