BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC

    MDR report key: 2496480 · Received March 14, 2012

    Report

    Report Number
    1625425-2012-00028
    Event Type
    Malfunction
    Date Received
    March 14, 2012
    Date of Event
    February 23, 2012
    Report Date
    March 14, 2012
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ARGON PICC BROKE INTO SEVERAL PIECES DURING THE PICC INSERTION PROCESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK