FDA Adverse Event
Malfunction
Summary report: N
DIGNISHIELD STOOL MANAGEMENT SYSTEM
MDR report key: 19190932
·
Received April 26, 2024
Report
- Report Number
- 19190932
- Event Type
- Malfunction
- Date Received
- April 26, 2024
- Date of Event
- April 8, 2024
- Report Date
- April 12, 2024
- Manufacturer
- C. R. BARD, INC.
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT (NURSING HOME RESIDENT) HAD FECAL MANAGEMENT DEVICE IN PLACE, BUT APPEARED TO HAVE STOPPED DRAINING. BAG WAS CHANGED FROM ONE INCLUDED IN THE INITIAL KIT TO A REPLACEMENT BAG, A LARGE AMOUNT OF STOOL DRAINED. MANUFACTURER RESPONSE FOR STOOL MANAGEMENT SYSTEM, DIGNISHIELD STOOL MANAGEMENT SYSTEM (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO BD CUSTOMER SERVICE AT 1-844-823-5433 ON 4/12/24. CONTAMINATED EQUIPMENT WAS DISCARDED DUE TO INFECTION CONTROL PRACTICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2308173 | DIGNISHIELD STOOL MANAGEMENT SYSTEM | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | C. R. BARD, INC. | SMS002 | NGHY1311 OR NGHY0549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male |