BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM
Report
- Report Number
- 1018233-2022-02129
- Event Type
- Death
- Date Received
- April 8, 2022
- Date of Event
- March 7, 2022
- Report Date
- October 4, 2022
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- KNT
- PMA / PMN Number
- K133251
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "MATERIALS OF CONSTRUCTION ARE NOT BIOCOMPATIBLE". THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "AS WITH THE USE OF ANY RECTAL DEVICE, THE FOLLOWING ADVERSE EVENTS MAY OCCUR: EXCESSIVE LEAKAGE OF STOOL AROUND THE DEVICE. LOSS OF ANAL SPHINCTER MUSCLE TONE WHICH COULD LEAD TO TEMPORARY OR PERMANENT ANAL SPHINCTER DYSFUNCTION. PRESSURE NECROSIS OF RECTAL OR ANAL MUCOSA. INFECTION. BOWEL OBSTRUCTION. PERFORATION OF THE BOWEL. RECTAL BLEEDING. RECTAL TEAR. ULCERATION OF RECTAL/ANAL MUCOSA." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "PHYSICIAN ERROR". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. BASED ON THE RESULTS OF THE INVESTIGATION, NO ADDITIONAL ACTIONS ARE NEEDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "AS WITH THE USE OF ANY RECTAL DEVICE, THE FOLLOWING ADVERSE EVENTS MAY OCCUR: EXCESSIVE LEAKAGE OF STOOL AROUND THE DEVICE LOSS OF ANAL SPHINCTER MUSCLE TONE WHICH COULD LEAD TO TEMPORARY OR PERMANENT ANAL SPHINCTER DYSFUNCTION. PRESSURE NECROSIS OF RECTAL OR ANAL MUCOSA. INFECTION. BOWEL OBSTRUCTION. PERFORATION OF THE BOWEL. RECTAL BLEEDING. RECTAL TEAR. ULCERATION OF RECTAL/ANAL MUCOSA." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BOWEL PERFORATION WHILE USING THE DIGNISHIELD BOWEL MANAGEMENT SYSTEM. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL FROM THE REGION COMPLAINT COORDINATOR (RCC) ON 21MAR2022, THE BD CLINICAL SPECIALIST STATED THE DIGNISHIELD DEVICE WAS INSERTED ON (B)(6) 2022. THE PATIENT EXPERIENCED MASSIVE HEMORRHAGING AND HEMATEMESIS ON (B)(6) 2022. ON (B)(6) 2022, A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED, WHICH REVEALED A PERFORATION IN THE RECTUM. THE PATIENT¿S SISTER FURTHER STATED THE PATIENT HAD BEEN SITTING IN A CHAIR WITH THE DIGNISHIELD IN PLACE. IT WAS ALSO REPORTED THAT THE PATIENT LATER EXPIRED. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL ON 23MAR2022 FROM THE RCC, THE CLINICAL SPECIALIST STATED THE PATIENT DID NOT UNDERGO ANY SURGERY FOLLOWING THESE EVENTS, AND THE TREATMENT WAS MANAGED CONSERVATIVELY. IT WAS CONFIRMED THAT THE PATIENT HAD A MASSIVE BLEED AND A SECOND EPISODE OF HEMATEMESIS. THERE WAS NO IMPROVEMENT IN THE PATIENT¿S CONDITION, AND THE PATIENT PASSED AWAY. A CLINICAL FOLLOW-UP WAS ATTEMPTED VIA EMAIL ON 24MAR2022. THE BD CLINICAL SPECIALIST RESPONDED ON 28MAR2022 AND PROVIDED CONTACT INFORMATION FOR A STAFF MEMBER ON THE UNIT WHERE THE EVENT OCCURRED. ADDITIONAL CLINICAL FOLLOW-UPS VIA EMAIL WERE ATTEMPTED ON 28MAR2022 AND 01APR2022, WITH NO RESPONSE RECEIVED. DESPITE GOOD FAITH EFFORTS, NO ADDITIONAL INFORMATION WAS OBTAINED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BOWEL PERFORATION WHILE USING THE DIGNISHIELD BOWEL MANAGEMENT SYSTEM. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL FROM THE REGION COMPLAINT COORDINATOR (RCC) ON 21MAR2022, THE BD CLINICAL SPECIALIST STATED THE DIGNISHIELD DEVICE WAS INSERTED ON (B)(6) 2022. THE PATIENT EXPERIENCED MASSIVE HEMORRHAGING AND HEMATEMESIS ON (B)(6) 2022. ON (B)(6) 2022, A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED, WHICH REVEALED A PERFORATION IN THE RECTUM. THE PATIENT¿S SISTER FURTHER STATED THE PATIENT HAD BEEN SITTING IN A CHAIR WITH THE DIGNISHIELD IN PLACE. IT WAS ALSO REPORTED THAT THE PATIENT LATER EXPIRED. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL ON 23MAR 2022 FROM THE RCC, THE CLINICAL SPECIALIST STATED THE PATIENT DID NOT UNDERGO ANY SURGERY FOLLOWING THESE EVENTS, AND THE TREATMENT WAS MANAGED CONSERVATIVELY. IT WAS CONFIRMED THAT THE PATIENT HAD A MASSIVE BLEED AND A SECOND EPISODE OF HEMATEMESIS. THERE WAS NO IMPROVEMENT IN THE PATIENT¿S CONDITION, AND THE PATIENT PASSED AWAY. A CLINICAL FOLLOW-UP WAS ATTEMPTED VIA EMAIL ON 24MAR 2022. THE BD CLINICAL SPECIALIST RESPONDED ON 28MAR 2022 AND PROVIDED CONTACT INFORMATION FOR A STAFF MEMBER ON THE UNIT WHERE THE EVENT OCCURRED. ADDITIONAL CLINICAL FOLLOW-UPS VIA EMAIL WERE ATTEMPTED ON 28MAR 2022 AND 01APR 2022, WITH NO RESPONSE RECEIVED. DESPITE GOOD FAITH EFFORTS, NO ADDITIONAL INFORMATION WAS OBTAINED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BOWEL PERFORATION WHILE USING THE DIGNISHIELD BOWEL MANAGEMENT SYSTEM. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL FROM THE REGION COMPLAINT COORDINATOR (RCC) ON 21MAR2022, THE BD CLINICAL SPECIALIST STATED THE DIGNISHIELD DEVICE WAS INSERTED ON (B)(6) 2022. THE PATIENT EXPERIENCED MASSIVE HEMORRHAGING AND HEMATEMESIS ON (B)(6) 2022. ON (B)(6) 2022, A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED, WHICH REVEALED A PERFORATION IN THE RECTUM. THE PATIENT¿S SISTER FURTHER STATED THE PATIENT HAD BEEN SITTING IN A CHAIR WITH THE DIGNISHIELD IN PLACE. IT WAS ALSO REPORTED THAT THE PATIENT LATER EXPIRED. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL ON 23MAR2022 FROM THE RCC, THE CLINICAL SPECIALIST STATED THE PATIENT DID NOT UNDERGO ANY SURGERY FOLLOWING THESE EVENTS, AND THE TREATMENT WAS MANAGED CONSERVATIVELY. IT WAS CONFIRMED THAT THE PATIENT HAD A MASSIVE BLEED AND A SECOND EPISODE OF HEMATEMESIS. THERE WAS NO IMPROVEMENT IN THE PATIENT¿S CONDITION, AND THE PATIENT PASSED AWAY. A CLINICAL FOLLOW-UP WAS ATTEMPTED VIA EMAIL ON 24MAR2022. THE BD CLINICAL SPECIALIST RESPONDED ON 28MAR2022 AND PROVIDED CONTACT INFORMATION FOR A STAFF MEMBER ON THE UNIT WHERE THE EVENT OCCURRED. ADDITIONAL CLINICAL FOLLOW-UPS VIA EMAIL WERE ATTEMPTED ON 28MAR2022 AND 01APR2022, WITH NO RESPONSE RECEIVED. DESPITE GOOD FAITH EFFORTS, NO ADDITIONAL INFORMATION WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1188537 | BARD® DIGNISHIELD® STOOL MANAGEMENT SYSTEM | STOOL MANAGEMENT SYSTEM | KNT | C.R. BARD, INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |