BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC 26GA, SINGLE LUMEN

    MDR report key: 6075378 · Received November 3, 2016

    Report

    Report Number
    1625425-2016-00079
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 7, 2016
    Report Date
    November 2, 2016
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 26 G FIRST PICC CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER WAS FLUSHED WITH WATER AND A LEAK WAS OBSERVED JUST ABOVE THE FIRST TICK MARK, CONFIRMING THE COMPLAINT. A VERY FAINT, SMALL SLIT COULD BE SEEN AT THAT LOCATION. POTENTIAL CONTRIBUTORS TO CATHETER LEAKAGE INCLUDE ADVANCING/REMOVING THE CATHETER OR STYLET DESPITE RESISTANCE, OR IMPROPER CATHETER SECUREMENT TECHNIQUES OR MAINTENANCE. THESE CAN ALSO INCLUDE FLUSHING THE CATHETER WITH EXCESS FORCE (E.G. USING A SYRINGE SMALLER THAN 10 ML, FLUSHING THE CATHETER DESPITE EXPERIENCING RESISTANCE, FLUSHING THE CATHETER USING A 10 ML SYRINGE WITH EXCESS PRESSURE, ETC.) WHICH CAN WEAKEN THE CATHETER. FIRST PICC CATHETERS ARE 100% IN-PROCESS INSPECTED AT VARIOUS TIMES DURING MANUFACTURE. CATHETERS ARE ALSO LEAK, FLOW, AND BURST TESTED TO ENSURE THEIR INTEGRITY. ADDITIONALLY, THE INSTRUCTIONS FOR USE INDICATE SEVERAL WAYS USERS CAN MITIGATE THE OCCURRENCE OF LEAKAGE. THE COMPLAINT MAY BE RELATED TO THE HANDLING OF THE DEVICE IN THE USER ENVIRONMENT.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE LINE WAS PLACED IN THE SCALP VEIN OF AN INFANT AND WAS IN PLACE FOR A PERIOD OF 5-10 MINUTES. UPON FLUSHING WITH NORMAL SALINE SOLUTION THEY NOTICED A LEAK IN THE LINE AND THE LINE WAS REMOVED. THERE WAS NO MECHANICAL STABILIZATION DEVICE IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728959 FIRST PICC 26GA, SINGLE LUMEN FIRST PICC FOZ ARGON MEDICAL DEVICES INC. 11143623

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention