FDA Adverse Event
Other
Summary report: N
MEDISYSTEMS AV FISTULA NEEDLE
MDR report key: 474029
·
Received July 23, 2003
Report
- Report Number
- MW1029101
- Event Type
- Other
- Date Received
- July 23, 2003
- Manufacturer
- MEDISYSTEM CORP
- Product Code
- FEI
- Report Source
- Voluntary report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WHEN PT WAS CANNULATED AND CONNECTED TO THEIR HIP THE VENOUS NEEDLE MADE A (POP) SOUND AND A BLOOD STREAM EXPRESSED FROM THE NEEDLE. LINES WERE CLAMPED, BLOOD CATHETER WERE DRAWN. THE LIFELINE NEEDLE WAS PULLED AND PT WAS RECANNULATED, AND CONNECTED TO TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDISYSTEMS AV FISTULA NEEDLE | FISTULA NEEDLE | FEI | MEDISYSTEM CORP | D9-2005MG | 2612F1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |