BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM

    MDR report key: 24228926 · Received January 30, 2026

    Report

    Report Number
    1018233-2026-00480
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 19, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KNT
    UDI-DI
    00801741045943
    PMA / PMN Number
    K133251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    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: 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.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND TO BE A DUPLICATE OF AN EVENT PREVIOUSLY REPORTED 1018233-2026-00513. 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 DIGNISHIELD PRODUCT USED ON A PATIENT WAS POSSIBLY DEFECTIVE: DIGNISHIELD GRM# (B)(4), REF# (B)(4). THE INCIDENT REPORT WAS COMPLETED BY THE NURSE, WHO NOTED THE SUSPECTED PRODUCT DEFECT. ON (B)(6) 2026, AROUND NOON, THE DIGNISHIELD TUBE WAS INSERTED. ON (B)(6) 2026, AROUND 5:00 AM, THE NURSE OBSERVED A DISCHARGE FROM THE RECTUM AND FOLLOWED TROUBLESHOOTING STEPS BY CHECKING THE CONDITION OF THE BALLOON. WHEN IT WAS DEFLATED THROUGH THE INFLATION PORT, STOOL WAS FOUND INSIDE THE BALLOON CONTENTS. THE ENTIRE DIGNISHIELD SYSTEM WAS SUBSEQUENTLY REPLACED. DURING A QUICK VISUAL INSPECTION OF THE REMOVED TUBE, IT APPEARED THAT THE SOURCE OF THE LEAK MIGHT HAVE BEEN DUE TO A MANUFACTURING ISSUE. THE BOX OF THE DEFECTIVE PRODUCT REMAINED IN THE ROOM, AS THE TUBE HAD BEEN INSERTED FOR LESS THAN 24 HOURS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DIGNISHIELD PRODUCT USED ON A PATIENT WAS POSSIBLY DEFECTIVE: DIGNISHIELD GRM# (B)(4), REF# SMS002. THE INCIDENT REPORT WAS COMPLETED BY THE NURSE, WHO NOTED THE SUSPECTED PRODUCT DEFECT. ON (B)(6) 2026, AROUND NOON, THE DIGNISHIELD TUBE WAS INSERTED. ON (B)(6) 2026, AROUND 5:00 AM, THE NURSE OBSERVED A DISCHARGE FROM THE RECTUM AND FOLLOWED TROUBLESHOOTING STEPS BY CHECKING THE CONDITION OF THE BALLOON. WHEN IT WAS DEFLATED THROUGH THE INFLATION PORT, STOOL WAS FOUND INSIDE THE BALLOON CONTENTS. THE ENTIRE DIGNISHIELD SYSTEM WAS SUBSEQUENTLY REPLACED. DURING A QUICK VISUAL INSPECTION OF THE REMOVED TUBE, IT APPEARED THAT THE SOURCE OF THE LEAK MIGHT HAVE BEEN DUE TO A MANUFACTURING ISSUE. THE BOX OF THE DEFECTIVE PRODUCT REMAINED IN THE ROOM, AS THE TUBE HAD BEEN INSERTED FOR LESS THAN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349353 BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM DIGNISHIELD KNT C.R. BARD INC. (COVINGTON) -1018233 NGKQ3449 00801741045943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other