BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP FOLEY TRAY SYSTEM

    MDR report key: 7978815 · Received October 17, 2018

    Report

    Report Number
    MW5080634
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Manufacturer
    BARD MEDICAL/ C.R. BARD INC.
    Product Code
    MJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS FILED TO REPORT FOLEY CATHETER LEAKAGE FROM A VENT PORT THAT HAS AFFECTED AT LEAST 5 PATIENTS. FACILITY INFECTION CONTROL DEPT. IS WORKING WITH BARD; EAST COAST FACILITIES HAVE HAD RECENT SIMILAR REPORTS. BARD IS ACTIVELY INVESTIGATING THE ISSUE AND IS CHANGING THE PRODUCT BACK TO THE (PRIOR DESIGNED) SYSTEM WITHOUT THE EXTRA VENT PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817172 SURESTEP FOLEY TRAY SYSTEM CATHETER, UROLOGICAL (ANTIMICROBIAL AND ACCESSORIES) MJC BARD MEDICAL/ C.R. BARD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1