BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19049394 · Received April 5, 2024

    Report

    Report Number
    1018233-2024-01870
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 11, 2024
    Report Date
    June 11, 2024
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    MJC
    PMA / PMN Number
    K984136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS UNCONFIRMED. VISUAL EVALUATION NOTED RECEIVED 1 DRAINAGE BAG WITH INLET TUBING, SAMPLE PORT CONNECTOR, AND SILICONE FOLEY CATHETER ATTACHED. RETURNED CATHETER CONTAINED MUSHROOMED BALLOON. RETURNED CATHETER WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER. THE CATHETER INFLATED AND DEFLATED WITH NO DIFFICULTIES. SOLUTION FLUSHED INTO INLET TUBING INTO BAG AND FLOWED FREELY WITH NO DIFFICULTIES. ALSO RECEIVED 8 PHOTO SAMPLES: PHOTO SAMPLE 1: TOP VIEW OF BAG CONNECTED TO CATHETER, PHOTO SAMPLE 2: TOP VIEW OF BAG WITH INLET PORT, PHOTO SAMPLE 3: TOP VIEW OF BACK OF BAG, PHOTO SAMPLE 4: TOP VIEW OF CATHETER, PHOTO SAMPLE 5: ZOOMED IN SHOWING SIDE PROFILE OF END OF CATHETER WITH DEFLATED MUSHROOMED BALLOON, PHOTO SAMPLE 6: ZOOMED IN SHOWING SAMPLE PORT CONNECTOR WITH BLUE CONNECTOR FLUSHED AND SEALED, PHOTO SAMPLE 7: ZOOMS IN ON LOT NUMBER LISTED ON BAG WHICH IS 230540, PHOTO SAMPLE 8: ZOOMS IN ON INFLATION CAP WITH PCN LISTED AS 2758J12 AND LOT NUMBER LISTED AS NGGY5693. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. DHR REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED HOWEVER DHR REVIEW WAS COMPLETED PRIOR TO SAMPLE EVALUATION. LABELLING REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS UNCONFIRMED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE URINE WAS NOT FLOWING OUT AND THE ISSUE WAS FOUND 4-5 HOURS AFTER BEING DETAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE URINE WAS NOT FLOWING OUT AND THE ISSUE WAS FOUND 4-5 HOURS AFTER BEING DETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017958 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER SILICONE FOLEY CATHETER MJC C.R. BARD INC. (COVINGTON) -1018233 NGGY5693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other