FDA Adverse Event
Other
Summary report: N
BARD FOLEY TRAY
MDR report key: 1623665
·
Received March 2, 2010
Report
- Report Number
- MW5015014
- Event Type
- Other
- Date Received
- March 2, 2010
- Date of Event
- February 1, 2010
- Report Date
- March 2, 2010
- Manufacturer
- C.R. BARD INC.
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
PT'S FOLEY CATHETER FELL TO THE FLOOR WHEN PT WAS STANDING. INSPECTION SHOWED THAT THE BALLOON AT THE CATHETER TIP WAS MISSING. PHYSICIAN WAS NOTIFIED IMMEDIATELY THAT BALLOON WAS MISSING. CYSTOSCOPY WAS SCHEDULED TO BE PERFORMED ON (B) (6) 2010, BUT WAS CANCELLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD FOLEY TRAY | FOLEY TRAY | KOD | C.R. BARD INC. | BARDEX LUBRICATH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |