BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 1993614 · Received January 6, 2011

    Report

    Report Number
    3006260740-2011-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A CHR OF LOT #RESA0276 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC PLACED ON (B)(6) 2010 - THE PATIENT WAS HAVING CHEMOTHERAPY ADMINISTERED - IT WAS OBSERVED THAT DURING ADMINISTRATION ON (B)(6) 2010 THAT LEAKAGE OF CHEMOTHERAPY WAS OBSERVED AT THE EXIT SITE. THE PICC LINE WAS REMOVED AND A HOLE WAS OBSERVED IN THE PICC APPROXIMATELY 4CM FROM THE EXIT SITE INSIDE THE PATIENTS VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT LJS C. R. BARD INC. (BASD) RESA0276

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention