BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® FOLEY CATHETER SILICONE COATED

    MDR report key: 8748466 · Received July 1, 2019

    Report

    Report Number
    1018233-2019-03472
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Report Date
    July 1, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741095207
    PMA / PMN Number
    K922431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    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:ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE BALLOON TO BURST. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. NOTE: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. BARDIA AND BARD ARE REGISTERED TRADEMARKS OF C.R. BARD, INC. OR AN AFFILIATE. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. ® SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SYRINGE. DO NOT USE NEEDLE. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. RECOMMENDED INFLATION CAPACITIES. 5CC BALLOON: USE 10CC STERILE WATER, 30CC BALLOON: USE 35CC STERILE WATER. DO NOT EXCEED RECOMMENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS CLOGGED, THE COMPLAINANT REPORTED THAT THIS MIGHT HAVE BEEN DUE TO AN INFECTION THE PATIENT HAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540701 BARDIA® FOLEY CATHETER SILICONE COATED FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 123618A UNK 00801741095207

    Patients

    Seq Age Sex Outcome Treatment
    1