FDA Adverse Event
Malfunction
Summary report: N
SURESTEP FOLEY TRAY SYSTEM 16FR, URINE METER, NRL
MDR report key: 20797686
·
Received November 26, 2024
Report
- Report Number
- MW5162925
- Event Type
- Malfunction
- Date Received
- November 26, 2024
- Date of Event
- November 5, 2024
- Report Date
- November 20, 2024
- Manufacturer
- C. R. BARD, INC.
- Product Code
- EZL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
RN INSERTED FOLEY CATHETER UNDER USUAL STERILE FASHION PER ORDER INTO URETHRA AND GOT URINE RETURN. RN STARTED TO INFLATE BALLOON WHEN RN HEARD AUDIBLE POP OF BALLOON INSIDE OF PATIENT. RN REMOVED FOLEY. BALLOON APPEARS INTACT UPON REMOVAL, SALINE VISUALIZED TRICKLING FROM PATIENT'S URETHRA. ANOTHER FOLEY WAS INSERTED WITHOUT DIFFICULTY. FAULTY FOLEY REFERENCE NUMBER: (B)(4) SURESTEP FOLEY TRAY SYSTEM 16FR, (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2613558 | SURESTEP FOLEY TRAY SYSTEM 16FR, URINE METER, NRL | CATHETER, RETENTION TYPE, BALLOON | EZL | C. R. BARD, INC. | A942216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Female |