BEUDAMED
    FDA Adverse Event Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY

    MDR report key: 3223574 · Received July 10, 2013

    Report

    Report Number
    3006260740-2013-00338
    Date Received
    July 10, 2013
    Report Date
    June 26, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    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 FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REWF0309 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    PICC THAT NEEDED REPAIR DUE TO INTERNAL LEAK. NO OTHER INFORMATION REGARDING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315383 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY LJS C. R. BARD INC. (BASD) REWF0309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention