BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG 9.5 FR D/L CV CATHETER

    MDR report key: 1362373 · Received March 26, 2009

    Report

    Report Number
    3006260740-2009-00121
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Report Date
    March 2, 2009
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K860256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED, BUT THE EXACT CAUSE IS UNK. ONE TAB WAS RECEIVED SEPARATE FROM THE PEEL-APART INTRODUCER SHEATH. THE SHEATH HAD BEEN SPLIT BY THE USER. THE END OF THE SHEATH THAT WAS ATTACHED TO THE TAB WAS TORN. A CHR OF LOT# RESH0517 SHOWED NO OTHER SIMILAR COMPLAINT(S) FROM THIS LOT. 213840.

    Description of Event or Problem · 1

    THE TABS BREAK OFF THE INTRODUCERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 9.5 FR D/L CV CATHETER FOZ C. R. BARD, INC. (BASD) RESH0517

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention