Bard® DigniShield® Stool Management System with ENFit™ ENSMS002Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00801741113147), received between Sep 20, 2019 and Aug 3, 2026 — classified as 7 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50110042 ↗
• MalfunctionJul 27, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50026503 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED PHYSICIAN INDICATED "DEATH". PRIOR TO DEVICE PLACEMENT AND INDICATED LEAKAGE OF STOOL AROUND THE DEVICE AFTER DEVICE PLACEMENT AND INDICATED THE LEAKAGE OF STOOL AROUND THE DEVICE TO BE DISEASE OR OTHER RELATED AND STATED "DEATH". ADDITIONALLY, THE RESPONDENT INDICATED HOSPICE WHEN ASKED WHAT INDICATION THE DEVICE WAS USED FOR IN RELATION TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389364 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED PHYSICIAN INDICATED LEAKAGE OF STOOL AROUND THE DEVICE AFTER PLACEMENT OF THE DEVICE AND INDICATED THE COMPLICATION TO BE DISEASE OR OTHER RELATED AND STATED CRITICAL ILLNESS IN RELATION TO THE DEVICE ENFIT DIGNISHIELD STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24378859 ↗
• MalfunctionFeb 18, 2026Fitting Problem

  IT WAS REPORTED IN AN ONLINE SURVEY BY THE CRITICAL CARE NURSES THAT PHYSICIAN INDICATED TISSUE INJURY (NECROSIS, TEARS, EROSION, PERFORATION, BLEEDING) AFTER PLACEMENT OF THE DEVICE AND INDICATED THE COMPLICATION TO BE DISEASE OR OTHER RELATED AND STATED BEDRIDDEN. PATIENT OBESE BAG WOULD NOT SECURE WELL IN RELATION TO THE DEVICE ENFIT DIGNISHIELD STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378851 ↗
• MalfunctionFeb 18, 2026Positioning Failure

  IT WAS REPORTED BY THE CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT PHYSICIAN INDICATED LEAKAGE OF STOOL AROUND THE DEVICE AFTER PLACEMENT OF THE DEVICE AND INDICATED THE COMPLICATION TO BE DISEASE OR OTHER RELATED AND STATED POOR DEVICE POSITIONING. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT HAD AN INFECTION, BOWEL OBSTRUCTION, AND ABDOMINAL DISTENSION PRIOR TO DEVICE PLACEMENT IN RELATION TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378848 ↗
• InjuryFeb 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED PHYSICIAN STATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002, AND THE PATIENT EXPERIENCED TISSUE INJURY(NECROSIS, TEARS, EROSION, PERFORATION, BLEEDING) AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Necrosis; Skin Tears

  MAUDE report 24378847 ↗
• InjuryFeb 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED IN AN ONLINE SURVEY BY THE CRITICAL CARE NURSES THAT PHYSICIAN INDICATED TISSUE INJURY (NECROSIS, TEARS, EROSION, PERFORATION, BLEEDING) AFTER PLACEMENT OF THE DEVICE AND INDICATED THE COMPLICATION TO BE DISEASE OR OTHER RELATED AND STATED BEDRIDDEN. PATIENT OBESE BAG WOULD NOT SECURE WELL IN RELATION TO THE DEVICE ENFIT DIGNISHIELD STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Erosion; Necrosis; Skin Tears

  MAUDE report 24378475 ↗
• MalfunctionNov 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BARD RECTAL TUBE MALFUNCTION: TWO OF THEM THE IRRIGATION PORT BROKE AND STOOL LEAKED EVERYWHERE. THE LAST ONE ACTUALLY HAD A SMALL TEAR WHERE THE TUBING COMES OUT OF THE RECTUM, ALONG THE SEAM RESULTING IN LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522784 ↗
• MalfunctionNov 11, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BARD RECTAL TUBE MALFUNCTION: TWO OF THEM THE IRRIGATION PORT BROKE AND STOOL LEAKED EVERYWHERE. THE LAST ONE ACTUALLY HAD A SMALL TEAR WHERE THE TUBING COMES OUT OF THE RECTUM, ALONG THE SEAM RESULTING IN LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522780 ↗
• MalfunctionNov 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BARD RECTAL TUBE MALFUNCTION: TWO OF THEM THE IRRIGATION PORT BROKE AND STOOL LEAKED EVERYWHERE. THE LAST ONE ACTUALLY HAD A SMALL TEAR WHERE THE TUBING COMES OUT OF THE RECTUM, ALONG THE SEAM RESULTING IN LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522770 ↗
• MalfunctionNov 11, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BARD RECTAL TUBE MALFUNCTION: TWO OF THEM THE IRRIGATION PORT BROKE AND STOOL LEAKED EVERYWHERE. THE LAST ONE ACTUALLY HAD A SMALL TEAR WHERE THE TUBING COMES OUT OF THE RECTUM, ALONG THE SEAM RESULTING IN LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522767 ↗
• MalfunctionJun 4, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT DIGNISHILED WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR PATIENT IN RELATION TO THE DEVICE ENFIT DIGNISHIELD STOOL MANAGEMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140354 ↗
• MalfunctionJun 3, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PRODUCT WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR PATIENT BECAUSE IN RELATION TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133977 ↗
• MalfunctionJun 3, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PRODUCT WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR PATIENT BECAUSE IN RELATION TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133972 ↗
• MalfunctionJun 2, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PRODUCT WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR PATIENT BECAUSE THE PATIENT WAS VERY AGITATED AND RESTLESS IN BED AND PRODUCT CAME OUT A COUPLE OF TIMES IN RELATION TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124542 ↗
• MalfunctionMay 30, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT DIGNISHIELD WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR PATIENT " BECAUSE " NOT SURE IF" IN RELATION TO THE DEVICE "ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM" WITH PRODUCT CODE " ENSMS002".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114158 ↗
• MalfunctionMay 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR PATIENT BECAUSE THE PATIENT HAD SEVERE LEAKAGE AROUND THE RECTUM AND IT DID NOT FULLY DIVERT STOOL INTO THE COLLECTION BAG. THE PATIENT WAS INTUBATED AND VERY SICK AND WAS DIFFICULT TO CLEAN UP FREQUENTLY IN RELATION TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114145 ↗
• MalfunctionMay 30, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT DIGNISHILED WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR PATIENT BECAUSE IN RELATION TO THE DEVICE "ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM" WITH PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114110 ↗
• MalfunctionMay 30, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT CRITICAL CARE NURSE REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT "NO, THE PRODUCT WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR YOUR PATIENT" IN RELATION TO THE DEVICE "ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM" WITH PRODUCT CODE "ENSMS002".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114092 ↗
• MalfunctionMay 30, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PRODUCT WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR PATIENT IN RELATION TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE ENSMS002.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114088 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE ENFIT DIGNISHIELD® STOOL MANAGEMENT SYSTEM WITH PRODUCT CODE: ENSMS002, AND THE PATIENT EXPERIENCED TISSUE INJURY (NECROSIS, TEARS, EROSION, PERFORATION, BLEEDING) AND IT DID NOT RESULT IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Erosion; Necrosis; Skin Tears

  MAUDE report 22113611 ↗
• MalfunctionMay 29, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THEY WERE NOT ABLE TO SUCCESSFULLY COLLECT A SAMPLE VIA THE SAMPLE PORT WHEN USING THE DIGNISHIELD DEVICE ON THE PATIENT BECAUSE BLOCKED PORT IN RELATION TO THE DEVICE ENFIT DIGNISHIELD STOOL MANAGEMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107222 ↗
• MalfunctionMay 29, 2025Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT CUSTOMER WAS NOT ABLE TO SUCCESSFULLY DELIVER MEDICATION TO THE PATIENT WHEN USING THE DIGNISHIELD DEVICE BECAUSE IT WAS NOT CLEARING WITH THE C DIFF IN RELATION TO THE DEVICE ENFIT DIGNISHIELD STOOL MANAGEMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105999 ↗
• MalfunctionMay 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DIGNISHIELD WAS NOT SUCCESSFULLY ABLE TO DIVERT AND COLLECT LIQUID OR SEMI-LIQUID STOOL FOR THE SPECIFIED DURATION OF USE FOR YOUR PATIENT BECAUSE UNSURE ABOUT WHY, BUT STOOL WAS LEAKING SIGNIFICANTLY AROUND THE TUBE. AFTER TROUBLESHOOTING UNSUCCESSFULLY, THEY ENDED UP REPLACING THE TUBE IN RELATION TO THE DEVICE ENFIT DIGNISHIELD STOOL MANAGEMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105992 ↗