MAUDE Adverse Event Report: C. R. BARD, INC. BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Product Quality Problem (1506); Structural Problem (2506)

Patient Problems Hemorrhage/Bleeding (1888); Ulcer (2274); No Code Available (3191)

Event Date 02/24/2020

Event Type  Injury  

Event Description

Patient was an elderly male with cirrhosis in the icu for management of encephalopathy.A fecal management system (fms) was placed for incontinence and lactulose enemas.Four days later, the patient reported significant pressure and urge to have a bowel movement.Previous shift reported that the fms had no output, even after irrigation, but noted some bleeding around the anus.On removal of the fms, roughly 130ml was extracted from the inflation tube (45ml standard practice) and the patient expelled 200ml of dark blood-clot like stool.Patient developed hematochezia and hemorrhagic shock requiring transfer to the medical intensive care unit (micu).On the micu, patient received massive transfusion protocol.Endoscopic evaluation revealed the source of bleeding as a rectal ulcer (likely pressure induced) and a hemostatic clip was placed.Patient subsequently required a repeat procedure, and vasopressors to stabilize.We have two concerns with the design of this device.One is that it lacks a visual indicator of overinflation, which other systems have.Second, the fms port and irrigation port are adjacent to each other and can be mistaken for each other.They both can receive standard syringes.

Event Description

Patient was an elderly male with cirrhosis in the icu for management of encephalopathy.A fecal management system (fms) was placed for incontinence and lactulose enemas.Four days later, the patient reported significant pressure and urge to have a bowel movement.Previous shift reported that the fms had no output, even after irrigation, but noted some bleeding around the anus.On removal of the fms, roughly 130ml was extracted from the inflation tube (45ml standard practice) and the patient expelled 200ml of dark blood-clot like stool.Patient developed hematochezia and hemorrhagic shock requiring transfer to the medical intensive care unit (micu).On the micu, patient received massive transfusion protocol.Endoscopic evaluation revealed the source of bleeding as a rectal ulcer (likely pressure induced) and a hemostatic clip was placed.Patient subsequently required a repeat procedure, and vasopressors to stabilize.We have the following design concerns: ¿although the lines are color coded ¿ they are adjacent/level with each other that can result in the wrong line being identified for inflation ¿inflation lines accept standard syringes that creates the potential for administrations to occur with the inflation line ¿there is no color indicator when the fms has been overinflated ¿when deflating the device, some residual fluid is left in the device that may lead to over inflation when re-inflated.

• Brand Name: BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10181493
• MDR Text Key: 196570278
• Report Number: 10181493
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24455 DA