BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L POLY RADPICC W/70 CM PLATINUM TIP GUIDEWIRE

    MDR report key: 1230859 · Received November 6, 2008

    Report

    Report Number
    3006260740-2008-00193
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 29, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    UPON PLACING A PICC LINE IN INTERVENTIONAL SUITE, UNDER X-RAY GUIDANCE, A FOREIGN BODY WAS NOTED IN THE PT'S SKIN. FOREIGN BODY WAS REMOVED PRIOR TO INSERTION OF PICC LINE AND SENT TO PATHOLOGY. IT WAS DETERMINED THAT THE FOREIGN BODY WAS A PIECE OF INTRODUCER WIRE WHICH SHEARED OFF DURING INITIAL ATTEMPT AT INSERTION OF PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR S/L POLY RADPICC W/70 CM PLATINUM TIP GUIDEWIRE LJS C. R. BARD INC. (BASD) RESF0780

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention