BEUDAMED
    FDA Adverse Event Summary report: N

    4 FR S/L GROSHONG PICC

    MDR report key: 1011479 · Received March 10, 2008

    Report

    Report Number
    2523003-2008-00005
    Date Received
    March 10, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K871998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT IN 2007, A PICC WAS PLACED IN THE RIGHT UPPER ARM, IN 2008, LEAKAGE WAS FOUND DURING THE INFUSION. THE EXAMINATION REVEALED THE CATHETER FRACTURED AT 2 CM ABOVE THE PUNCTURE POINT, IMMEDIATELY IDENTIFIED THE CATHETER THROUGH FILMS WAS FOUND IN THE PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR S/L GROSHONG PICC LJS C.R. BARD, INC. (BASD) RERD0197

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention