BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MEDICAL SURESTEP FOLEY TRAY SYSTEM 16FR

    MDR report key: 15104718 · Received July 25, 2022

    Report

    Report Number
    MW5111112
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 12, 2022
    Report Date
    July 22, 2022
    Manufacturer
    BARD MEDICAL /C.R. BARD, INC.
    Product Code
    MJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FOLEY CATHETER REMOVED FROM PATIENT - CATHETER TIP MISSING UPON REMOVAL. PATIENT CONTINUED TO VOID WITHOUT DIFFICULTY. PELVIC X-RAY AND CONSULT TO UROLOGY MADE. UROLOGY PERFORMED OUTPATIENT CYSTOSCOPY ON (B)(6) 2022 - NO FOREIGN BODY FOUND AT THIS TIME. POSSIBLE PATIENT PASSED TIP WITHOUT NOTICE OR FURTHER INCIDENT. NO HARM. THE FOLEY WAS FROM THE BARD MEDICAL KIT SURESTEP FOLEY TRAY SYSTEM - 16 FR. REFERENCE # A303316A, LOT # NGFZ4358. UNFORTUNATELY, NO PHOTO OF FOLEY WITH MISSING TIP OR RETAINMENT OF PRODUCT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432968 BARD MEDICAL SURESTEP FOLEY TRAY SYSTEM 16FR CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES MJC BARD MEDICAL /C.R. BARD, INC. NGFZ4358

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention