FDA Adverse Event
Malfunction
Summary report: N
LUBRI-SIL I.C. COMPLETE CARE FOLEY CATHETER TRAY
MDR report key: 12108499
·
Received July 1, 2021
Report
- Report Number
- MW5102273
- Event Type
- Malfunction
- Date Received
- July 1, 2021
- Date of Event
- June 29, 2021
- Report Date
- June 30, 2021
- Manufacturer
- BARD MEDICAL / C.R. BARD, INC.
- Product Code
- EZL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FOUR (4) LUBRI-SIL IC COMPLETE CARE URINARY CATHETER TRAYS OPENED WITH EACH HAVING A DISCOLORED (TAN TO BROWN COLOR) URINARY CATHETER; 3 KITS NGEX4788 EXP: 2023-01-31, 1 KIT NGEY3206, EXP: 2023-03-31. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 994569 | LUBRI-SIL I.C. COMPLETE CARE FOLEY CATHETER TRAY | CATHETER, RETENTION TYPE, BALLOON | EZL | BARD MEDICAL / C.R. BARD, INC. | 303416A | NGEX4788 | |
| 994570 | LUBRI-SIL I.C. COMPLETE CARE FOLEY CATHETER TRAY | CATHETER, RETENTION TYPE, BALLOON | EZL | BARD MEDICAL / C.R. BARD, INC. | 303416A | NGEX4788 | |
| 994571 | LUBRI-SIL I.C. COMPLETE CARE FOLEY CATHETER TRAY | CATHETER, RETENTION TYPE, BALLOON | EZL | BARD MEDICAL / C.R. BARD, INC. | 303416A | NGEX4788 | |
| 994572 | LUBRI-SIL I.C. COMPLETE CARE FOLEY CATHETER TRAY | CATHETER, RETENTION TYPE, BALLOON | EZL | BARD MEDICAL / C.R. BARD, INC. | 303416A | NGEY3206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |