BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER

    MDR report key: 9235361 · Received October 24, 2019

    Report

    Report Number
    1018233-2019-06784
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 24, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741039843
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS UNCONFIRMED SINCE THE REPORTED FAILURE COULD NOT BE REPRODUCED. IT WAS UNKNOWN IF THE PRODUCT WAS USED FOR TREATMENT OR DIAGNOSIS. VISUAL INSPECTION NOTED ONE TEMPERATURE SENSING CATHETER OPEN WITH ORIGINAL PACKAGING WAS RECEIVED. VISUAL EVALUATION OF THE SAMPLE NOTED NO OBVIOUS DEFECTS. FURTHER TESTING WAS REQUIRED. THE CATHETER BALLOON WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND THE BALLOON CONCENTRICITY WAS OBSERVED TO BE 60:40. THE BALLOON RESTED FOR 30 MINUTES WITHOUT LEAKS AND PASSIVELY DEFLATED WITHOUT ISSUE OR CUFFING, RETURNING 10ML OF SOLUTION. THE DRAINAGE LUMEN WAS ALSO FLUSHED WITH METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML OF DISTILLED WATER) WITHOUT LEAKS. ACTIVE LENGTH OF THE CATHETER BALLOON WAS MEASURED (0.7940") AND FOUND TO BE WITHIN SPECIFICATION (0.60" - 0.90"). THE CATHETER MEASURED TO BE 14 FR. A POTENTIAL ROOT CAUSE COULD NOT BE FOUND SINCE THE REPORTED EVENT WAS UNCONFIRMED. NEITHER A DHR REVIEW NOR A MANUFACTURING REVIEW WERE COMPLETED BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿TO DEFLATE AND REMOVE THE BALLOON, ATTACH A NEEDLELESS SYRINGE TO LET STERILE WATER IN THE BALLOON COME OUT SPONTANEOUSLY THROUGH BALLOON DEFLATION WITHOUT ASPIRATION. AFTER BALLOON DEFLATION, WITHDRAW THE CATHETER SLOWLY WHILE CONFIRMING THAT NO ABNORMAL RESISTANCE IS ENCOUNTERED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRACK WAS FOUND ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028408 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER TEMPERATURE SENSING CATHETER (SILICONE) MJC C.R. BARD, INC. (COVINGTON) -1018233 119314 NGCW2522 00801741039843

    Patients

    Seq Age Sex Outcome Treatment
    1