BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD® LARGE NYLON CATHETER PLUG

    MDR report key: 23330333 · Received October 17, 2025

    Report

    Report Number
    1018233-2025-09315
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 5, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KNY
    UDI-DI
    10801741046244
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE LABELING IS FOUND TO BE ADEQUATE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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 PATIENT HAD A FOLEY, DRAIN BAG AND FOLEY PLUG. PATIENT HAS BEEN GETTING INFECTIONS CONSTANTLY AND WOULD LIKE TO KNOW HOW TO CLEAN THE FOLEY PLUG BETTER. UPON TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT WAS USING RUSCH FOLEY, CARDINAL DRAINAGE BAG AND BD FOLEY PLUG, 0414L. EXPLAINED WE HAVE NO CLEANING INFORMATION FOR THIS PLUG AND IT WAS NON-STERILE. SUGGESTED A STERILE FOLEY PLUG FROM MEDLINE AND REACH OUT TO HER HCP. CALLER WAS UNHAPPY WITH THIS INFORMATION AND HUNG UP. FORWARDED INFORMATION TO COMPLAINTS. IT IS UNKNOWN WHAT MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A FOLEY, DRAIN BAG AND FOLEY PLUG. PATIENT HAS BEEN GETTING INFECTIONS CONSTANTLY AND WOULD LIKE TO KNOW HOW TO CLEAN THE FOLEY PLUG BETTER. UPON TROUBLESHOOTING, IT WAS NOTED THAT THE PATIENT WAS USING RUSCH FOLEY, CARDINAL DRAINAGE BAG AND BD FOLEY PLUG, 0414L. EXPLAINED WE HAVE NO CLEANING INFORMATION FOR THIS PLUG AND IT WAS NON-STERILE. SUGGESTED A STERILE FOLEY PLUG FROM MEDLINE AND REACH OUT TO HER HCP. CALLER WAS UNHAPPY WITH THIS INFORMATION AND HUNG UP. FORWARDED INFORMATION TO COMPLAINTS. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297975 BARD® LARGE NYLON CATHETER PLUG CATHETER PLUG KNY C.R. BARD INC. (COVINGTON) -1018233 UNK 10801741046244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other