Bard® DigniShield® Stool Management System Collection Bags SMS2B1LRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741045967), received between Jan 8, 2019 and Jun 12, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT FLUSH PORT COMPLETELY DISCONNECTED FROM THE TUBING AND LEAKED STOOL. ADDITIONALLY, THE SEAL OF THE END OF THE TUBING CLOSEST TO THE DIGNISHIELD SMS COLLECTION BAG BY THE GREEN LATCH THAT LOCKS IT TO THE BAG WAS CONTINUOUSLY LEAKING STOOL ONTO THE FLOOR. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 10JUN2025, STATED THAT THIS WAS AROUND THE 6TH OR 7TH DEVICE THAT HAD FAILED IN A SIMILAR MANNER IN THE PAST FEW MONTHS. ALL OTHERS HAD BEEN DISCARDED BY THE STAFF, SO THEY WERE UNABLE TO SEND THEM BACK FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193759 ↗
• MalfunctionApr 25, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER HAD ORDERED 10 EACH PER CASE OF DIGNICARE STOOL MANAGEMENT SYSTEM COLLECTION BAGS, BUT THEY ONLY RECEIVED THE BAG AND NOT THE OTHER COMPONENTS. CUSTOMER STATED THAT BASED ON THE MANUFACTURER PART NUMBER SMS2B1L, IT APPEARED THE ITEM SHOULD COME WITH THE FOLLOWING: A CATHETER TUBE ASSEMBLY, A 60CC SYRINGE, A COLLECTION BAG, A SYRINGE OF LUBRICATING JELLY, A BIOLOGICAL ODOR ELIMINATOR AND A TUBE CLAMP. THE DEVICE HAS NO COMPONENTS MADE OF NATURAL RUBBER LATEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192164 ↗
• MalfunctionMar 29, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE QUANTITY OF DIGNISHIELD COLLECTION BAG MEASURE WAS NOT ACCURATE. FOR EXAMPLE, LIQUID WITHIN THE BAG WILL READ 150 ML WHEN HELD LEVEL, BUT WHEN EMPTIED IT MEASURES 100 ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935353 ↗
• MalfunctionMar 21, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER HAD ORDERED 10 EACH PER CASE OF DIGNICARE STOOL MANAGEMENT SYSTEM COLLECTION BAGS, BUT THEY ONLY RECEIVED THE BAG AND NOT THE OTHER COMPONENTS. CUSTOMER STATED THAT BASED ON THE MANUFACTURER PART NUMBER SMS2B1L, IT APPEARED THE ITEM SHOULD COME WITH THE FOLLOWING: A CATHETER TUBE ASSEMBLY, A 60CC SYRINGE, A COLLECTION BAG, A SYRINGE OF LUBRICATING JELLY, A BIOLOGICAL ODOR ELIMINATOR AND A TUBE CLAMP. THE DEVICE HAS NO COMPONENTS MADE OF NATURAL RUBBER LATEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839694 ↗
• MalfunctionApr 30, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT BAG WAS MISSING IN THE DIGNISHIELD COLLECTION BAG KIT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755887 ↗
• MalfunctionJul 3, 2020Fluid/Blood Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DIGNISHIELD RECTAL TUBE BOWEL IRRIGATION PORT FOR BOWEL MEDICATION ALLEGEDLY LEAKED WHILE ATTEMPTING TO INJECT DILUTED MEDICATION WITH A LUER-LOCK SYRINGE. SUPPOSEDLY, THE VALVE IN THE PORT CAME OUT AND WOULD BE ATTACHED TO THE SYRINGE. HOWEVER, IF REPLACED IT WOULD LEAK AGAIN. THE RECTAL TUBE WAS REPLACED AND KEPT TO BE SUBMITTED BACK TO THE COMPANY FOR ASSESSMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10228228 ↗
• MalfunctionJan 8, 2019Misassembled; Failure to Cut; No Flow; Misassembled

  IT WAS REPORTED THAT THE DIGNISHIELD BAG CONNECTION WAS NOT PERFORATED/CUT AND WOULD NOT ALLOW STOOL DRAINAGE IF CONNECTED TO A PATIENT. THIS WAS NOTED PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8228728 ↗