BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC

    MDR report key: 2191468 · Received July 27, 2011

    Report

    Report Number
    3006260740-2011-00258
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    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 MFR AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD PICC PLACED ON RIGHT SIDE (B)(6) 2011. HAD X5 TREATMENTS OF OXALIPLATIN VIA PICC. ON (B)(6) 2011, PT HAVING DRESSING CHANGED, UPON FLUSHING LEAKAGE AT EXIT SITE OBSERVED. PICC REMOVED AND FRACTURE OF LINE OBSERVED AT 43CM, LINE INSERTED TO 45CM. NO HISTORY OF OCCLUSION. REMOVAL OF PICC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC LJS C. R. BARD INC. (BASD) REUK1219

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention