BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH

    MDR report key: 3750202 · Received January 3, 2014

    Report

    Report Number
    3007207906-2013-00009
    Event Type
    Other
    Date Received
    January 3, 2014
    Date of Event
    December 4, 2013
    Report Date
    January 2, 2014
    Manufacturer
    NEO MEDICAL INC.
    Product Code
    DQY
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR BASED ON OUR MDR REPORTING CRITERIA. A F/U REPORT WILL BE SUBMITTED, HOWEVER, THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION. AN INVESTIGATION ANALYSIS WILL BE COMPLETED ((B)(6)).

    Description of Event or Problem · 1

    CATHETER HAD SEVERAL HOLES IN THE PATH OF THE EPICUTANEOUS LINE REMOVED AFTER 3 DAYS WHEN HOLES WERE NOTICED. PATIENT DID NOT REQUIRE ANY INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2804 V-CATH V-CATH DQY NEO MEDICAL INC. 355-72 1119

    Patients

    Seq Age Sex Outcome Treatment
    1