FDA Adverse Event
Malfunction
Summary report: N
ADDTO CATHETER ADAPTER
MDR report key: 14083918
·
Received April 12, 2022
Report
- Report Number
- 14083918
- Event Type
- Malfunction
- Date Received
- April 12, 2022
- Date of Event
- February 4, 2022
- Report Date
- March 16, 2022
- Manufacturer
- ADDTO, INC.
- Product Code
- EYI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
AFTER COMPLETING A BLADDER INSTILLATION FOR A BCG TREATMENT, THE CATHETER ADAPTER SEPARATED FROM THE PHASEAL OPTIMA CLOSED SYSTEM CONNECTOR WHEN REMOVING. THEREFORE, THE ADD TO CATHETER ADAPTER REMAINED IN THE END OF THE CATHETER. THERE WAS NO PATIENT HARM. THE PLAN OF CARE REMAINED UNCHANGED AS IT REQUIRED THAT THE CATHETER BE REMOVED AFTER THE BCG INSTALLATION AND A NEW CATHETER BE INSERTED AS PER STANDARD. THE CATHETER ADAPTER REMAINED SNUGLY AT THE END OF THE FOLEY CATHETER. HOWEVER, IF IT HAD MIGRATED, IT COULD HAVE RESULTED IN PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1246892 | ADDTO CATHETER ADAPTER | ADAPTOR, URETERAL CATHETER | EYI | ADDTO, INC. | 2219 | 726 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30660 DA | Male |