BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH PICC

    MDR report key: 2818464 · Received October 25, 2012

    Report

    Report Number
    2925153-2012-00009
    Event Type
    Other
    Date Received
    October 25, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 24, 2012
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    DQY
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR BASED ON OUR MDR REPORTING CRITERIA. (B)(6) HAS CONFIRMED IN THE E-MAIL THAT THE END USER DID NOT USE PADDED FORCEPS AS RECOMMENDED IN IFU. OTHER DEVICES NOT SUPPLIED OR MANUFACTURED BY NEO MEDICAL WERE USED WITH NEO MEDICAL PRODUCT 355-72 FOR PLACEMENT. (B)(6) STATES "POSSIBLY THE USE OF THE BD INTRODUCER IS CONTRIBUTION TO THESE PROBLEMS. IFU ATTACHED. FOLLOW UP WILL BE PROVIDED AS ADDITIONAL INFORMATION IS RECEIVED AND COMPLAINT INVESTIGATION ANALYSIS ((B)(4)) IS COMPLETED.

    Description of Event or Problem · 1

    FIRST LINE A LEAK WAS NOTICED AROUND HUB. SECOND LINE HOLES WERE NOTED AT 2-3CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC 2FR SL V-CATH DQY NEO MEDICAL, INC. 355-72 1111

    Patients

    Seq Age Sex Outcome Treatment
    1