BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGON MEDICAL DEVICES

    MDR report key: 3020699 · Received March 18, 2013

    Report

    Report Number
    MW5029441
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IS A (B)(6) PREMATURE INFANT IN THE NICU AT (B)(6) HOSP. ARGON 26GAUGE 1.9 FR PICC CATHETER BROKE IN HALF BELOW THE WIDE HUB OUTSIDE OF THE PT. BLOOD BACKED UP THROUGH THE END OF THE CATHETER THAT REMAINED IN THE PT. CATHETER REMOVED FROM THE INFANT WITHOUT DIFFICULTY. HAD OCCURRENCE OF THE SAME ISSUE WITH THE SAME CATHETER IN (B)(6) 2011 AND (B)(6) 2012 NOT REPORTED TO THE FDA. HAVE HEARD ANECDOTAL REPORTS OF THIS PROBLEM OCCURRING AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112133 ARGON MEDICAL DEVICES FIRST PICC S/L PERIPHERALLY INSERTED CENTRAL CATHETER LJS ARGON MEDICAL DEVICES 11029979

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Required Intervention