BEUDAMED
    FDA Adverse Event Other Summary report: N

    V CATH MIDLINE OTN

    MDR report key: 2197734 · Received July 29, 2011

    Report

    Report Number
    2925153-2011-00011
    Event Type
    Other
    Date Received
    July 29, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 27, 2011
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ASSESSED AND DETERMINED TO BE AN MDR REPORT BASED ON OUR MDR REPORTING CRITERIA. THE INFO PROVIDED BY (B)(6) ADVERSE INCIDENT REPORT INDICATES THAT THE DEVICE IN QUESTION IS WITH CF NURSE SPECIALIST, A REQUEST FOR THE DEVICE TO BE RETURNED HAS BEEN SENT. (B)(6) REPORT ATTACHED. FOLLOW UP REPORT WILL BE PROVIDED UPON THE COMPLETION OF THE DEVICE EXAMINATION PROCESS. (PENDING RETURN OF DEVICE TO (B)(4)).

    Description of Event or Problem · 1

    (B)(6) ADVERSE INCIDENT REPORT STATES, ON (B)(6) 2011, CHILD GRABBED LINE AND LINE SNAPPED AT HUB. ON (B)(6) 2011, LINE SNAPPED AT HUB WHILE SYRINGE BEING CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V CATH MIDLINE OTN V-C ML MINI OTN FOZ NEO MEDICAL, INC. 355-78 1022 (UNSURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention