BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH PICC (POWER-V)

    MDR report key: 1671506 · Received April 27, 2010

    Report

    Report Number
    2925153-2009-00008
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    September 28, 2009
    Report Date
    April 9, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREVIOUSLY ASSESSED IN (B)(6) 2009 AND THE DECISION WAS THERE WAS NO INDICATION FOR MDR REPORTING, BASED ON THE EXISTING MDR DECISION TREE. THIS COMPLAINT FILE WAS REVIEWED BY THREE FDA INSPECTORS AND THE CONTENTS DID NOT WARRANT A MDR REPORT FILING. NEOMEDICAL HAS UPDATED ITS COMPLAINT HANDLING AND MDR REPORTING PROCEDURES. THE 2009 AND 2010 COMPLAINT FILES WERE RE-EXAMINED AND BASED ON THE CHANGED CRITERIA THIS MDR REPORT IS BEING FILED. AN EXAMINATION OF THE DEVICE WAS NEEDED TO CLARIFY THE ISSUE REPORTED, HOWEVER, THE PRODUCT SAMPLE WAS DISCARDED BY THE USER.

    Description of Event or Problem · 1

    BASED ON THE REPORT, REPORTED TO NEOMEDICAL ON (B)(6) 2009, THE TWO LUMENS OF THE DUAL LUMEN CATHETER WERE INTERCONNECTED, "CROSS TALKING". AN OVER WIRE EXCHANGE WITH ANOTHER NEOMEDICAL DUAL POWER PICC WITH LOT NUMBER 1012 WAS DONE. THIS REPLACEMENT CATHETER PERFORMED FLAWLESSLY. THE PATIENT IS OK AND THE USED CATHETER/SAMPLE WAS DISCARDED BY THE NURSE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC (POWER-V) VASCULAR ACCESS DEVICE LJS NEOMEDICAL 5070-2660 1012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention