BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIRST PICC

    MDR report key: 2012226 · Received February 2, 2011

    Report

    Report Number
    1625425-2011-00011
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    December 2, 2010
    Report Date
    January 13, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF DEVICE EVAL WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN SAMPLE IS RECEIVED.

    Description of Event or Problem · 1

    PART OF CATHETER BROKE OFF (3 TO 4CM PIECE) AND FLOATED. INFANT WAS TRANSFERRED TO (B)(6) HOSPITAL - (B)(6) FOR SURGERY. CATHETER PIECE COULD NOT BE RETRIEVED. DECISION WAS MADE TO REMOVE THE PIECE ONCE THE INFANT IS OLDER AND MORE STABLE. WILL SEND INTACT PART OF CATHETER WHEN AVAILABLE FROM (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC FOZ ARGON MEDICAL DEVICES, INC. NA 0175348

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention