BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH SL PICC

    MDR report key: 2197758 · Received July 29, 2011

    Report

    Report Number
    2925153-2011-00012
    Event Type
    Other
    Date Received
    July 29, 2011
    Date of Event
    May 29, 2011
    Report Date
    July 27, 2011
    Manufacturer
    NEO MEDICAL, INC
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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)(4) ADVERSE INCIDENT REPORT INDICATES THAT THE DEVICE IN QUESTION IS NOT AVAILABLE FOR EVAL. FOLLOW UP REPORT WILL BE PROVIDED UPON THE COMPLETION OF THE DEVICE MFG LOT HISTORY AND REVIEW OF PRODUCT COMPLAINT IN CAPA MEETING.

    Description of Event or Problem · 1

    (B)(4) ADVERSE INCIDENT REPORTS (B)(4) STATES, PICC LINE SNAPPED WHERE THE LINE GOES FROM WIDE TO NARROW. FULL LINE REMOVED. NO DETAILS OF INJURY TO PT PROVIDED, NO INFO REGARDING ACTION TAKEN WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH SL PICC V-CATH SL PICC DQY NEO MEDICAL, INC 355-75 1102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention