BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOMEDICAL V-CATH PICC

    MDR report key: 1730147 · Received June 11, 2010

    Report

    Report Number
    2925153-2010-00008
    Event Type
    Other
    Date Received
    June 11, 2010
    Date of Event
    May 11, 2010
    Report Date
    June 11, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ASSESSED AND DETERMINED TO BE A MDR REPORT BASED ON OUR MDR REPORTING CRITERIA. BASED ON ALL THE INFORMATION PROVIDED WITH THE REPORT THE EVENT IS DUE TO USER ERROR. THE CATHETER WAS PULLED BACK OUT OF THE NEEDLE / INTRODUCER AND THE IFU PROVIDED WITH THE PRODUCT CLEARLY STATES THAT THIS SHOULD NOT BE DONE. AN EXAMINATION OF THE DEVICE AS PART OF THE INVESTIGATION CONFIRMED THE USER ERROR. THIS INFORMATION HAS BEEN COMMUNICATED TO THE REPORTING PERSON(S).

    Description of Event or Problem · 1

    BASED ON THE REPORT INFORMATION SUBMITTED TO NEOMEDICAL ON (B)(6) 2010, THE CATHETER BROKE INSIDE THE PATIENT'S VEIN. THE PRODUCT CODE IS # 355-70, LOT # 1059. FOLLOW UP INFORMATION STATED "PICC INSERTED INTO RIGHT ANTECUBITAL FOSSA, THREADED APPROXIMATELY 8 CM, WOULD NOT ADVANCE BUT FLUSHED EASILY, CATHETER PULLED BAC, ARM POSITION ADJUSTED, RE-THREADED BUT ONCE AGAIN WOULD NOT ADVANCE PAST 8 CM. NO PRESSURE OR FORCE APPLIED TO ADVANCE CATHETER. CATHETER REMOVED, 3 CM OF CATHETER MISSING FROM END. INSERTION SITE NOT BLEEDING, MISSING PIECE OF CATHETER MILKED OUT OF VEIN AND COMPLETE."THE USE SAMPLE WAS RETURNED AND EXAMINED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMEDICAL V-CATH PICC V-CATH 2 FR PICC DQY NEOMEDICAL 355-70 1159

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention