BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POURCHEZ RETRO & SAFE TRAC COMBO KIT, TIP TO CUFF 23CM

    MDR report key: 3851844 · Received April 11, 2014

    Report

    Report Number
    3006260740-2014-00176
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    October 29, 2013
    Report Date
    March 20, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K022000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF ASVJ0002 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED OF SUSPECTED LEAKAGE OF THE RETRO CATHETER. PRODUCT SAMPLE AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221222 POURCHEZ RETRO & SAFE TRAC COMBO KIT, TIP TO CUFF 23CM MSD C.R. BARD, INC. (BASD) ASVJ0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention