BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EU PPICC SOLO, 4FR S/

    MDR report key: 2971086 · Received February 15, 2013

    Report

    Report Number
    3006260740-2013-00072
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K050931
    Adverse Event
    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 AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TREATMENT WITH CHEMIOTERAPIC THEY NOTED A POSSIBLE EXTRAVASATION. THEY GAVE TO THE PT AN ANTIDOTE. 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
    69687 EU PPICC SOLO, 4FR S/ LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention