BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)

    MDR report key: 24670389 · Received March 23, 2026

    Report

    Report Number
    1018233-2026-01948
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 27, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    KNT
    PMA / PMN Number
    K133251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 PRODUCT CATALOG NUMBER FOR THIS DEVICE IS UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PAST WEEKEND, A PATIENT IN ROOM 9408 EXPERIENCED A MALFUNCTION WITH AN FCD. THE GREEN BALLOON WATER INSTILLATION PORT WAS FOUND TO HAVE POPPED OFF AT AN UNKNOWN TIME, AS IT WAS NOT IN PLACE DURING FCD CARE AND WATER HAD LEAKED OUT. THIS WAS THE SECOND FCD PLACED. THE FCD USED THE PREVIOUS DAY REPORTEDLY HAD A TEAR IN THE GREEN BALLOON WATER INSTILLATION PORT AND REQUIRED REPLACEMENT. PREVIOUS ISSUES WITH THE PRODUCT HAD ALSO BEEN REPORTED, THOUGH NOT RECENTLY. GIVEN THAT TWO SEPARATE DEVICES MALFUNCTIONED ON CONSECUTIVE DAYS, THE ISSUE WAS CONSIDERED POTENTIALLY MORE THAN COINCIDENTAL AND WARRANTED FURTHER REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PAST WEEKEND, A PATIENT IN ROOM (B)(6) EXPERIENCED A MALFUNCTION WITH AN FCD. THE GREEN BALLOON WATER INSTILLATION PORT WAS FOUND TO HAVE POPPED OFF AT AN UNKNOWN TIME, AS IT WAS NOT IN PLACE DURING FCD CARE AND WATER HAD LEAKED OUT. THIS WAS THE SECOND FCD PLACED. THE FCD USED THE PREVIOUS DAY REPORTEDLY HAD A TEAR IN THE GREEN BALLOON WATER INSTILLATION PORT AND REQUIRED REPLACEMENT. PREVIOUS ISSUES WITH THE PRODUCT HAD ALSO BEEN REPORTED, THOUGH NOT RECENTLY. GIVEN THAT TWO SEPARATE DEVICES MALFUNCTIONED ON CONSECUTIVE DAYS, THE ISSUE WAS CONSIDERED POTENTIALLY MORE THAN COINCIDENTAL AND WARRANTED FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270972 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD) FECAL MANAGEMENT KNT C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1