FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 39747
·
Received September 26, 1996
Report
- Report Number
- 1219454-1996-00425
- Event Type
- Injury
- Date Received
- September 26, 1996
- Report Date
- September 26, 1996
- Manufacturer
- STRATO/INFUSAID, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 9/6/96, THE FACILITY OR MATERIAL MGR CONTACTED THE MFR AND REPORTED THAT THE PT'S NECK HAD SWOLLEN DURING CHEMOTHERAPY. IT WAS ADDITIONALLY STATED THAT THE CHEMO WAS NOT REMOVED FROM THE DEVICE; THE SWELLING WAS NOTICED DURING FLUSHING OF THE DEVICE. A FLUOROSCOPY WAS PERFORMED AND REVEALED LEAKAGE FROM THE DEVICE CATHETER AT THE "CURVE BEFORE ENTERING THE INTERNAL JUGULAR." NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM Implant | VASCULAR ACCESS DEVICE | LJT | STRATO/INFUSAID, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |