BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EU PPICC SOLO, 4 FR S/L

    MDR report key: 3060186 · Received April 11, 2013

    Report

    Report Number
    3006260740-2013-00151
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 22, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A LEAK IN THE CATHETER IS CONFIRMED. DURING FUNCTIONAL TESTING A SPRAYING LEAK WAS OBSERVED BETWEEN THE 8 AND 9 CM DEPTH MARKERS. GROSS AND MICROSCOPIC EXAMINATIONS REVEALED A LONGITUDINAL SPLIT IN THE CATHETER TUBING. A CROSS SECTIONAL VIEW OF THE SPLIT SITE REVEALS A DULL GRANULAR VENEER. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL AND MICROSCOPIC EXAMINATION, AS WELL AS FUNCTIONAL TESTING, REVEALED NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TREATMENT WITH CHEMOTHERAPY THEY NOTED A POSSIBLE EXTRAVASATION. THEY GAVE THE PATIENT AN ANTIDOTE. THE CATHETER WAS REMOVED AND THEY FOUND A LESION ON THE CATHETER AT 10 CM NEAR THE INTRAVASCULAR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155558 EU PPICC SOLO, 4 FR S/L LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention