BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER

    MDR report key: 6752367 · Received July 28, 2017

    Report

    Report Number
    1018233-2017-04027
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Report Date
    November 1, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FCM
    UDI-DI
    00801741030680
    PMA / PMN Number
    K910653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿STERILE CONTENTS OF KIT ARE STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR POVIDONE-IODINE SWABS WHICH ARE NOT TERMINALLY STERILIZED. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. ASSEMBLED IN (B)(6) BARD AND TOUCHLESS ARE REGISTERED TRADEMARKS OF C.R. BARD, INC. OR AN AFFILIATE". (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 KIT WAS MISSING THE IODINE PACKETS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KIT WAS MISSING THE IODINE PACKETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530576 BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER TOUCHLESS MALE INTERMITTENT CATHETER KIT FCM C.R. BARD, INC. (COVINGTON) -1018233 4A3053 NGAT4056 00801741030680

    Patients

    Seq Age Sex Outcome Treatment
    1