FDA Adverse Event
Malfunction
Summary report: N
SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY
MDR report key: 8623360
·
Received May 20, 2019
Report
- Report Number
- 8623360
- Event Type
- Malfunction
- Date Received
- May 20, 2019
- Date of Event
- April 18, 2019
- Report Date
- April 23, 2019
- Manufacturer
- C. R. BARD, INC.
- Product Code
- EZL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
CATHETER KIT MISSING STERILE GLOVES AND ONE STERILE SWAB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416671 | SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER TRAY | CATHETER, RETENTION TYPE, BALLOON | EZL | C. R. BARD, INC. | A942216 | NGCX1532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |