BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® CATHETER

    MDR report key: 15401571 · Received September 12, 2022

    Report

    Report Number
    15401571
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 12, 2022
    Manufacturer
    C. R. BARD, INC.
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REGISTERED NURSE ATTEMPTED TO INSERT 12 FR INDWELLING CATHETER- PRODUCT NUMBER A942212. WHEN INSERTED AND BALLOON INFLATED, FLUID LEAKED OUT OF INSERTION SITE AND CATHETER BECAME DISLODGED. NO INJURY TO PATIENT. WHEN ASSESSING PRODUCT, RN NOTED THAT BALLOON HAD A LEAK. RN REPORTED ISSUE AND DISCARDED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308080 SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® CATHETER CATHETER, RETENTION TYPE, BALLOON EZL C. R. BARD, INC. A942212

    Patients

    Seq Age Sex Outcome Treatment
    1 5840 DA Male