BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19546971 · Received June 17, 2024

    Report

    Report Number
    1018233-2024-03504
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    December 26, 2023
    Report Date
    May 29, 2024
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741039904
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS UNCONFIRMED. VISUAL EVALUATION NOTED RECEIVED 1 SILICONE FOLEY CATHETER WITH SYRINGE. USING RETURNED SYRINGE CATHETER WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER). INFLATED WITH NO DIFFICULTIES AND DEFLATED PASSIVELY UNDER ONE MINUTE. USING IN HOUSE LOCK LEUR SYRINGE CATHETER WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER). INFLATED WITH NO DIFFICULTIES AND DEFLATED PASSIVELY UNDER ONE MINUTE. DISSECTED BALLOON INDICATED INFLATION NOTCH WAS AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED EVENT IS UNCONFIRMED A LABELING REVIEW IS NOT REQUIRED. H11: SECTION A THROUGH F - 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 · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER DID NOT DEFLATE WHEN IT WAS CHECKED BEFORE INSERTION BY A LABOR AND DELIVERY NURSE. DEVICE WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322640 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER TEMPERATURE SENSING FOLEY CATHETER MJC C.R. BARD INC. (COVINGTON) -1018233 NGHS2842 00801741039904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other