BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH PICC 2.0FR SL

    MDR report key: 1978691 · Received January 28, 2011

    Report

    Report Number
    2925153-2011-00003
    Event Type
    Other
    Date Received
    January 28, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 26, 2011
    Manufacturer
    NEO MEDICAL, INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED SUMMARY WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    PICC LINE WAS INSERTED VIA RIGHT BASILLIC VEIN. THE LINE WAS FLUSHED USING A 10 ML SYRINGE. AT THIS POINT A LEAK WAS NOTED AT THE JUNCTION BETWEEN THE CATHETER AND THE MOULDING. DR. (B)(6), CONSULTANT NEONATOLOGIST, NEWBORN UNIT, (B)(6) HOSPITAL, (B)(6). DR. (B)(6) STATED, THAT NO FORM OF INTERVENTION NEEDED, NO RESISTANCE ENCOUNTERED DURING REMOVAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC 2.0FR SL PERIPHERALLY INSERTED CENTRAL CATHETER DQY NEO MEDICAL, INC 355-75 1104

    Patients

    Seq Age Sex Outcome Treatment
    1