BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC KIT W/INTROSTYLE INTRODUCER

    MDR report key: 2080093 · Received April 6, 2011

    Report

    Report Number
    1625425-2011-00037
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION WILL BE FILED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE FIRST PICC WAS LEAKING NEAR THE OVAL SHAPED JUNCTION. IT WAS LEAKING THE LIQUID DRUG. NO PT INJURY OR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST PICC KIT W/INTROSTYLE INTRODUCER FOZ ARGON MEDICAL DEVICES, INC. NA 0291089

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK