FDA Adverse Event
Injury
Summary report: N
BARD
MDR report key: 303427
·
Received November 2, 2000
Report
- Report Number
- 303427
- Event Type
- Injury
- Date Received
- November 2, 2000
- Date of Event
- October 13, 2000
- Report Date
- October 19, 2000
- Manufacturer
- CR BARD, QA
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- SC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FOLEY BALLOON DID NOT DEFLATE ALTHOUGH 10CC FLUID IN 10CC SYRINGE AND TUBING WAS COLLAPSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD | FOLEY CATHETER | KOD | CR BARD, QA | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| O |