BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGON 28 GAUGE SPLITTABLE NEEDLE INTRODUCER

    MDR report key: 2922261 · Received January 16, 2013

    Report

    Report Number
    MW5028625
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 2, 2013
    Manufacturer
    ARGON MEDICAL DEVICES, INC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARGON 28 GAUGE SPLITTABLE NEEDLE INTRODUCER DID NOT SPLIT CAUSING REMOVAL OF ENTIRE LINE. OTHER SAME DEVICES ON OTHER PTS: (B)(6) 2012, (B)(6) 2012 AND (B)(6) 2012 - SENT TO MFR. UPON THE EVENT ON (B)(6) 2012, ASKED BY OMC QUALITY TO REPORT TO MEDWATCH. THESE PICC'S WERE TO BE INSERTED FOR LONGTERM IV USE - DID NOT SPLIT PROPERLY ON INSERTION AND WERE REMOVED IMMEDIATELY. ALSO SEE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23660 ARGON 28 GAUGE SPLITTABLE NEEDLE INTRODUCER SPLITTABLE NEEDLE INTRODUCER FOZ ARGON MEDICAL DEVICES, INC 384061 11018328

    Patients

    Seq Age Sex Outcome Treatment
    1