Bard® DigniShield® Stool Management System SMS002Recalls & reported problems

Summary

The FDA's MAUDE database contains 525 adverse event reports that list this exact device (DI 00801741045943), received between Apr 29, 2017 and Sep 21, 2026 — classified as 2 deaths, 95 injuries, 428 malfunctions.

The most frequently reported specific device problem is “Disconnection” (95 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 525 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848823 ↗
• MalfunctionSep 21, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848697 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848292 ↗
• MalfunctionSep 10, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717391 ↗
• DeathAug 21, 2026Nonstandard Device

  It was reported that the DigniShield was used on a 43 year old immunocompromised female that was admitted through the emergency department at Hospital. The device was left in the rectum after visual evidence of blood in the collection bag. The presence of blood was mentioned to the Intensive Care Unit staff, and it was dismissed as being the patient's menstrual cycle. Menstrual blood was not evacuated through the rectum. The use of this device resulted in irreparable damage to the patient's rectum in the form of ulcers and fistulas. These fistulas became connected to the patient vagina, resulting in fungal infections of both candida and cryptococcus neoformans. The latter fungal infection played an integral role in the patient's death.

  Patient problems: Fistula; Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Ulcer

  MAUDE report 50377879 ↗
• MalfunctionJul 17, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25861359 ↗
• InjuryJun 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER USING DIGNISHIELD FOR 25 DAYS THE DAY AFTER REMOVAL OF THE FECAL CATHETER, THE PATIENT BEGINS WITH ANAL BLEEDING, SO SHE UNDERGOES A CONTROL COLONOSCOPY WHICH DETERMINES THAT THE BLEEDING IS COMING FROM THE NOTORIOUSLY MARKED AREA OF THE POSITIONING ZONE. ANAL BLEEDING WHICH SHOULD BE CHECKED BY COLONOSCOPY AND UNDERGO THE INDICATED TREATMENT.

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

  MAUDE report 25409295 ↗
• MalfunctionMay 16, 2026Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT USER HAVE ATTACHED SOME IMAGES FROM A LEAKING FLUSHING PORT BASE OF A DIGNISHIELD SYSTEM USED IN INTENSIVE CARE UNIT 3. THEY WERE SAYING ABOUT 10% OF THE FLUSH AND NUMBER 2 IN LIQUID FORM CAME OUT FROM THE SEAL. THE DIGNISHIELD WAS ONLY INSERTED YESTERDAY. (2 DAYS OLD FMS). THE NURSES HAVE TRIED TO USE TEGADERM TO SEAL IT AND NO LEAKING HAS OCCURRED AFTER THIS INNOVATION WITH TEGADERM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196034 ↗
• MalfunctionMay 6, 2026Disconnection

  IT WAS REPORTED THAT THE FLUSH (PURPLE) AND INFLATION (GREEN) PATHS WENT OUT, DISCONNECTED, AFTER A WEEK'S USE OF THE DIGNISHIELD PRODUCT. PLEASE INVESTIGATE AS SOON AS POSSIBLE AND REPORT BACK TO THE CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096395 ↗
• MalfunctionMay 5, 2026Disconnection

  IT WAS REPORTED THAT THE FLUSH (PURPLE) AND INFLATION (GREEN) PATHS WENT OUT, DISCONNECTED, AFTER A WEEK'S USE OF THE DIGNISHIELD PRODUCT. PLEASE INVESTIGATE AS SOON AS POSSIBLE AND REPORT BACK TO THE CLIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089044 ↗
• InjuryMay 1, 2026Patient Device Interaction Problem

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT DEVELOPED A RECTAL BLEED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25060122 ↗
• MalfunctionApr 14, 2026Difficult to Remove

  IT WAS REPORTED THAT PRHC HAD TWO FAULTY RECTAL TUBE INCIDENTS. IN THE FIRST INCIDENT, THE DIGNISHIELD BALLOON HAD A SLOW LEAK AND FELL OUT. IN THE SECOND INCIDENT, THE BALLOON WOULD NOT DEFLATE TO REMOVE FROM THE PATIENT. THEY HAD 3 REMAINING FROM THIS LOT AND HAD BEEN INSTRUCTED NOT TO USE DUE TO PATIENT SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879605 ↗
• MalfunctionApr 14, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THEY HAD TWO FAULTY RECTAL TUBE INCIDENTS. THE FIRST ONE THE DIGNISHIELD BALLOON HAD A SLOW LEAK AND FELL OUT. THE SECOND ONE USED WOULD NOT DEFLATE TO REMOVE FROM THE PATIENT. THEY HAD 3 REMAINING FROM THAT LOT AND HAD BEEN INSTRUCTED NOT TO USE DUE TO PATIENT SAFETY. ARE THEY ABLE TO PLEASE GET A REFUND FOR THOSE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877964 ↗
• MalfunctionApr 14, 2026Difficult to Remove

  IT WAS REPORTED THAT THEY HAD TWO FAULTY RECTAL TUBE INCIDENTS. THE FIRST ONE THE DIGNISHIELD BALLOON HAD A SLOW LEAK AND FELL OUT. THE SECOND ONE USED WOULD NOT DEFLATE TO REMOVE FROM THE PATIENT. THEY HAD 3 REMAINING FROM THAT LOT AND HAD BEEN INSTRUCTED NOT TO USE DUE TO PATIENT SAFETY. ARE THEY ABLE TO PLEASE GET A REFUND FOR THOSE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877963 ↗
• MalfunctionApr 8, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT ON THE FIRST DAY OF PLACEMENT, REMOVED THE TUBE AND WAS GIVING IT A QUICK RINSE BEFORE INSERTING IT AGAIN WHEN NOTICED A HOLE IN THE TUBE AND SAW WATER SQUIRTING OUT OF IT. SINCE THE STOOL VOLUME WASN¿T PARTICULARLY LARGE, HADN¿T NOTICED THIS WHEN I FIRST PLACED IT. SINCE HADN¿T USED IT IN ANY UNUSUAL WAY, BELIEVE THIS IS A PRODUCT DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823546 ↗
• MalfunctionMar 31, 2026Tear, Rip or Hole in Device Packaging; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING USE THERE WAS A TEAR IN HOSE OF DIGNISHIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749708 ↗
• MalfunctionMar 17, 2026Disconnection; Material Fragmentation

  IT WAS REPORTED THAT THEY WERE TRANSFERRED A PATIENT FROM THE INTENSIVE CARE UNIT BED TO THE 3T BED WHEN THEY NOTICED THAT A PIECE OF THE DIGNICARE RECTAL TUBE HAD COME OFF DURING THE TRANSFER. THE PART THAT CAME OFF WAS THE GREEN PORT, WHICH WAS WHERE THEY INFLATE OR DEFLATE THE BULB TO THE TUBE WITH WATER. BEFORE TRANSFERRED TO THE FLOOR THEY WERE ABLE TO SUCCESSFULLY REMOVE THE OLD ONE THEY HAD TO CUT THE RECTAL TUBE AND THAT DEFLATED THE BULB AND PLACED A NEW ONE. AFTER ARRIVING TO 3T AND EXPLAINING WHAT HAPPENED, THEY WERE SHOWING THE 3T NURSES WHERE THE OLD ONE HAD BROKEN OFF. THEY LIGHTLY TOUCHED THAT FOR THEM TO SAW AND SOME OF THE PLASTIC HOLDING THE GREEN PORT ON, FELL OFF. IT ALMOST APPEARED THE ONLY THING HOLDING THAT ON WAS A SMALL AMOUNT OF GLUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622360 ↗
• MalfunctionMar 13, 2026Fracture; Material Fragmentation

  IT WAS REPORTED THAT ONE PROBE PARTIALLY BROKE THE CUFF JOINTS DURING TESTING, WITHOUT BEING INSTALLED. AFTERWARDS, I RECEIVED TWO MORE COPIES, WHICH ALSO BROKE DURING MANUAL VERIFICATION. IT WAS REPORTED THAT DURING THE COLLECTION CARRIED OUT BY THE CARRIER, WE IDENTIFIED THAT, IN ADDITION TO THE DIGNISHIELD UNIT CORRESPONDING TO THE LOT (NGJYY312) REPORTED IN THE COMPLAINT (B)(4), A SECOND UNIT WAS ALSO COLLECTED BELONGING TO LOT NGJS3478 FOR WHICH WE HAVE NO RECORD OF A COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590438 ↗
• MalfunctionMar 6, 2026Difficult to Remove

  IT WAS REPORTED THAT WITNESSES HAD PLACED THE BOWEL MANAGEMENT SYSTEM (BMS) ON 27 JAN AT THE 2200 TURN. THEY HAD EXPERIENCED SOME DIFFICULTY GETTING THE BALLOON TO FULLY DEFLATE BEFORE INSERTION. THE SYRINGE WAS REATTACHED WITH A FIRMER CONNECTION, AFTER WHICH THE BALLOON WAS DEFLATED AND INSERTED WITHOUT DIFFICULTY. WHEN THE BALLOON WAS FILLED WITH WATER AFTER INSERTION, THERE WAS SOME RESISTANCE, BUT IT WAS FULLY INFLATED USING A SLOWER INJECTION RATE. THE BOWEL MANAGEMENT SYSTEM WAS THEN FLUSHED, WITH FLUID AND STOOL RETURN OBSERVED. AT THE MIDNIGHT TURN, THE PATIENT WAS FOUND IN A LOT OF STOOLS. WITNESSES ATTEMPTED TO DEFLATE THE BALLOON TO REPOSITION THE BMS, BUT THEY WERE UNABLE TO DO SO BECAUSE THE BALLOON PORT AND LINE WERE CREATING A VACUUM WITH SUCTION FROM THE SYRINGE. THE PORT WAS CUT OFF TO ALLOW FOR GRAVITY DRAINAGE, BUT NO FLUID CAME OUT OF THE BALLOON. HEMOSTATS WERE USED TO OPEN THE BALLOON LINE ENOUGH TO INSERT A TOOMEY SYRINGE, AND WITH DIFFICULTY, WITNESSES WERE ULTIMATELY ABLE TO REMOVE THE FLUID AND THEN REMOVE THE BOWEL MANAGEMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537414 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WITNESSES HAD PLACED THE BOWEL MANAGEMENT SYSTEM (BMS) ON 27JAN AT THE 2200 TURN. THEY HAD EXPERIENCED SOME DIFFICULTY GETTING THE BALLOON TO FULLY DEFLATE BEFORE INSERTION. THE SYRINGE WAS REATTACHED WITH A FIRMER CONNECTION, AFTER WHICH THE BALLOON WAS DEFLATED AND INSERTED WITHOUT DIFFICULTY. WHEN THE BALLOON WAS FILLED WITH WATER AFTER INSERTION, THERE WAS SOME RESISTANCE, BUT IT WAS FULLY INFLATED USING A SLOWER INJECTION RATE. THE BOWEL MANAGEMENT SYSTEM WAS THEN FLUSHED, WITH FLUID AND STOOL RETURN OBSERVED. AT THE MIDNIGHT TURN, THE PATIENT WAS FOUND IN A LOT OF STOOLS. WITNESSES ATTEMPTED TO DEFLATE THE BALLOON TO REPOSITION THE BMS, BUT THEY WERE UNABLE TO DO SO BECAUSE THE BALLOON PORT AND LINE WERE CREATING A VACUUM WITH SUCTION FROM THE SYRINGE. THE PORT WAS CUT OFF TO ALLOW FOR GRAVITY DRAINAGE, BUT NO FLUID CAME OUT OF THE BALLOON. HEMOSTATS WERE USED TO OPEN THE BALLOON LINE ENOUGH TO INSERT A TOOMEY SYRINGE, AND WITH DIFFICULTY, WITNESSES WERE ULTIMATELY ABLE TO REMOVE THE FLUID AND THEN REMOVE THE BOWEL MANAGEMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535862 ↗
• MalfunctionMar 6, 2026Inflation Problem

  IT WAS REPORTED THAT WITNESSES HAD PLACED THE BOWEL MANAGEMENT SYSTEM (BMS) ON 1/27 AT THE 2200 TURN. THEY HAD EXPERIENCED SOME DIFFICULTY GETTING THE BALLOON TO FULLY DEFLATE BEFORE INSERTION. THE SYRINGE WAS REATTACHED WITH A FIRMER CONNECTION, AFTER WHICH THE BALLOON WAS DEFLATED AND INSERTED WITHOUT DIFFICULTY. WHEN THE BALLOON WAS FILLED WITH WATER AFTER INSERTION, THERE WAS SOME RESISTANCE, BUT IT WAS FULLY INFLATED USING A SLOWER INJECTION RATE. THE BOWEL MANAGEMENT SYSTEM WAS THEN FLUSHED, WITH FLUID AND STOOL RETURN OBSERVED. AT THE MIDNIGHT TURN, THE PATIENT WAS FOUND IN A LOT OF STOOLS. WITNESSES ATTEMPTED TO DEFLATE THE BALLOON TO REPOSITION THE BMS, BUT THEY WERE UNABLE TO DO SO BECAUSE THE BALLOON PORT AND LINE WERE CREATING A VACUUM WITH SUCTION FROM THE SYRINGE. THE PORT WAS CUT OFF TO ALLOW FOR GRAVITY DRAINAGE, BUT NO FLUID CAME OUT OF THE BALLOON. HEMOSTATS WERE USED TO OPEN THE BALLOON LINE ENOUGH TO INSERT A TOOMEY SYRINGE, AND WITH DIFFICULTY, WITNESSES WERE ULTIMATELY ABLE TO REMOVE THE FLUID AND THEN REMOVE THE BOWEL MANAGEMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535569 ↗
• MalfunctionMar 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ISSUES WITH DIGNISHIELD, SPECIFICALLY LEAKAGE CAUSED BY SMALL HOLES APPROXIMATELY 6 INCHES FROM THE INSERTION POINT. A NEW INCIDENT WAS REPORTED TODAY. THE DEVICE HAD BEEN PLACED ON 2/18 AT 09:28 IN THE CARDIAC UNIT. WHEN THE PATIENT ARRIVED IN THE ICU, STAFF OBSERVED LEAKAGE, AND THE TUBING APPEARED TO HAVE A SLASH NEAR THE SAME LOCATION (6 INCHES DOWN). THE LOT NUMBER WAS NOT AVAILABLE. THE DEVICE WAS REPLACED, AND NO FURTHER ISSUES WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508169 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE THREE PATIENTS HAD EXPERIENCED LEAKS DUE TO HOLES IN THE TUBING. THE PACKAGE SHOWN BELOW WAS COLLECTED FROM ONE OF THE AFFECTED PATIENTS. AT THE TIME OF REPORTING, IT WAS UNKNOWN WHETHER ADDITIONAL INCIDENTS HAD OCCURRED; HOWEVER, FOLLOW UP WITH OTHER INPATIENT LEADERS WAS PLANNED TO DETERMINE IF SIMILAR ISSUES WERE IDENTIFIED. PER ADDITIONAL INFORMATION RECEIVED ON 09FEB2026, IT WAS REPORTED AFTER VISITING THE HOSPITAL, THEY DID MENTION 1 MORE INSTANCE OF LEAKING NEAR THE INSERTION SITE, MAKING 4 INSTANCES OVER THE PAST 3 WEEKS. THEY WERE ONLY ABLE TO TALK TO ONE NURSE WHO SAID IT WAS A VERY SMALL TEAR ABOUT 8IN DOWN FROM THE INSERTION SITE. NURSE DID NOT KNOW HOW LONG IT HAD BEEN IN NOR WAS ADMINISTERING MEDICATION WHILE USING THE DEVICE. SHE DID REPLACE IT AND THEN HAD NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469457 ↗
• MalfunctionFeb 26, 2026Difficult to Remove

  IT WAS REPORTED THAT OVER THE WEEKEND, ICU STAFF HAD EXPERIENCED AN ISSUE WITH THE RECTAL TUBE SHOWN IN THE PHOTO. THE BALLOON OF THE RECTAL TUBE HAD BEEN UNABLE TO DEFLATE AFTER INFLATION, AND TROUBLESHOOTING ATTEMPTS HAD BEEN UNSUCCESSFUL. AS A RESULT, THE NURSE HAD PROCEEDED TO CUT THE RECTAL TUBE AT THE INFLATION PORT OR LINE IN ORDER TO DEFLATE IT AND REMOVE IT FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464319 ↗
• MalfunctionFeb 26, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ISSUES WITH DIGNISHIELD, SPECIFICALLY LEAKAGE CAUSED BY SMALL HOLES APPROXIMATELY 6 INCHES FROM THE INSERTION POINT. A NEW INCIDENT WAS REPORTED TODAY. THE DEVICE HAD BEEN PLACED ON (B)(6) AT 09:28 IN THE CARDIAC UNIT. WHEN THE PATIENT ARRIVED IN THE ICU, STAFF OBSERVED LEAKAGE, AND THE TUBING APPEARED TO HAVE A SLASH NEAR THE SAME LOCATION (ABOUT 6 INCHES DOWN). THE LOT NUMBER WAS NOT AVAILABLE. THE DEVICE WAS REPLACED, AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464306 ↗