BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR. S/L POWER PICC SOLO

    MDR report key: 2971244 · Received February 1, 2013

    Report

    Report Number
    3006260740-2013-00048
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 25, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TREATMENT WITH CHEMOTHERAPY, THE PT SUFFERED PAIN NEAR THE IMPLANT SEAT. THE CATHETER WAS REMOVED AND THEY FOUND A LESION OF THE CATHETER AT 10 CM NEAR THE INTRAVASCULAR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45391 4 FR. S/L POWER PICC SOLO LJS C. R. BARD INC. (BASD) REWG1281

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention