BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGROSHONG CATHETER 5F FULL TRAY (SINGLE-LUMEN) (45CM)

    MDR report key: 3770401 · Received February 18, 2014

    Report

    Report Number
    3006260740-2014-00058
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Report Date
    January 24, 2014
    Manufacturer
    C.R. BARD, INC (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REXF1846 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    SPLIT PICC JUST UNDER SKIN AT 35CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102297 POWERGROSHONG CATHETER 5F FULL TRAY (SINGLE-LUMEN) (45CM) LJS C.R. BARD, INC (BASD) REXF1846

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention