FDA Adverse Event
Injury
Summary report: N
C.R. BARD INC.
MDR report key: 189694
·
Received September 22, 1998
Report
- Report Number
- 189694
- Event Type
- Injury
- Date Received
- September 22, 1998
- Date of Event
- August 31, 1998
- Report Date
- September 10, 1998
- Manufacturer
- C.R. BARD, INC.
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHEN REMOVING SHEATH FROM THE R. FEMORAL VEIN, THE SHEATH BROKE OFF INSIDE OF THE PT. THE SHEATH WAS THEN REMOVED BY INSERTING ANOTHER SHEATH VIA L. GROIN AND A SNARE CATHETER WAS USED TO RETRIEVE THE BROKEN PORTION OF THE SHEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C.R. BARD INC. | 7 FR USCI SHEATH | DYB | C.R. BARD, INC. | 006059 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention |