BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP

    MDR report key: 11884530 · Received May 26, 2021

    Report

    Report Number
    11884530
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 21, 2021
    Manufacturer
    C. R. BARD, INC.
    Product Code
    MJC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FOLEY TIP WAS BENT AND CRIMPED. RN DID NOT FEEL LIKE THE CATHETER WAS SAFE TO USE ON THE PATIENT. THE PRODUCT DID NOT HAVE PATIENT CONTACT OR HARM. MANUFACTURER RESPONSE FOR TRAY URINE METER 14FR SURESTEP SIVER LATEX 051456, (BRAND NOT PROVIDED) (PER SITE REPORTER). QUALITY REPORT FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785016 SURESTEP CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES MJC C. R. BARD, INC. A303314A NGEZ3296

    Patients

    Seq Age Sex Outcome Treatment
    1 15695 DA