BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSH NXT 4 FR S/L PICC FULL

    MDR report key: 3853865 · Received April 16, 2014

    Report

    Report Number
    3006260740-2014-00184
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    March 25, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PICC LEAKING IN PORTION OF PICC BENEATH SKIN SURFACE AROUND 2 CM SUBCUTANEOUS. PICC EXCHANGE OVER WIRE PERFORMED I.E. WHOLE CATHETER REPLACED. PICC INSITU FOR 7 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233525 GROSH NXT 4 FR S/L PICC FULL CATHETER INTRAVASCULAR, THERAPEUTIC, LONG-TERM LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention