FDA Adverse Event
Death
Summary report: N
TESIO LOCK RIGHT ADAPTOR
MDR report key: 168290
·
Received May 18, 1998
Report
- Report Number
- 168290
- Event Type
- Death
- Date Received
- May 18, 1998
- Date of Event
- February 11, 1998
- Report Date
- May 8, 1998
- Manufacturer
- MED COMP
- Product Code
- LFJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT FOUND AT HOME WITH MASSIVE BLEEDING FROM LEFT SUBCLAVIAN CATHETER DOUBLE PORT FOR DIALYSIS. ONE OF THE PORTS WAS BROKEN (BLUE). PT ARRIVED IN ER, INTUBATED, AND IN ASYSTOLE. PT EXPIRED 02/11/98 0238.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TESIO LOCK RIGHT ADAPTOR | TESIO EXTENSION | LFJ | MED COMP | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Death |