BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES, SHORT

    MDR report key: 6138683 · Received December 1, 2016

    Report

    Report Number
    1018233-2016-01730
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    November 10, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    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: "RECOMMENDED INFLATION CAPACITIES: 3CC BALLOON: USE 5ML STERILE WATER; 5CC BALLOON: USE 10ML STERILE WATER; 30CC BALLOON: USE 35ML STERILE WATER; DO NOT EXCEED RECOMMENDED CAPACITIES. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE." (B)(4). 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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BALLOON BUSTED ONCE IT WAS INSERTED. THE CATHETER BALLOON WAS ALLEGEDLY FILLED WITH 5CC OF WATER. ONCE THE PATIENT BEGAN TO VOID, THE CATHETER BALLOON THEN BURSTS. THE INSERTED CATHETER ONLY LASTED ONE DAY BEFORE IT BURSTS. THE PATIENT ALLEGEDLY EXPERIENCED CONTINUOUS URINARY TRACT INFECTION THAT WERE TREATED WITH ANTIBIOTICS. THE PATIENT HAS NOT HAD A PHYSICIAN CHECK TO SEE IF ANY PIECES OF THE CATHETER BALLOON WERE LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789096 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES, SHORT FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention