BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2-WAY 5CC LATEX FOLEY CATHETER

    MDR report key: 5067833 · Received September 10, 2015

    Report

    Report Number
    1018233-2015-00342
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    June 4, 2015
    Report Date
    August 18, 2015
    Manufacturer
    BARD SDN. BHD. -8040607
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE." THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A URINARY TRACT INFECTION ON (B)(6) 2015 AS A RESULT OF USING THE CATHETER. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015 FOR ACUTE METABOLIC ENCEPHALOPATHY SECONDARY TO UNDERLYING URINARY RETENTION AND A URINARY TRACT INFECTION. A FOLEY CATHETER WAS PLACED AND 800MLS OF URINE WAS RETURNED. FOLLOW UP URINE CULTURES WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598737 2-WAY 5CC LATEX FOLEY CATHETER FOLEY CATHETER EZC BARD SDN. BHD. -8040607 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention