FDA Adverse Event
Injury
Summary report: N
FLEX II PC LJ/RS 15CM KI
MDR report key: 420679
·
Received October 3, 2002
Report
- Report Number
- 1720496-2002-00202
- Event Type
- Injury
- Date Received
- October 3, 2002
- Report Date
- September 4, 2002
- Manufacturer
- BARD REYNOSA S.A. DE C.V.
- Product Code
- MPB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THERE WAS A BREAK IN THE CATHETER JOINT ONLY AFTER A SHORT PERIOD (ABOUT A WEEK) OF USE. PATIENT INJURY WAS INDICATED DUE TO AN AIR EMBOLISM CAUSED BY THE BREAK. NO OTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEX II PC LJ/RS 15CM KI | SHORT TERM BLOOD ACCESS DEVICE | MPB | BARD REYNOSA S.A. DE C.V. | 5524150 | 22IK3491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |