FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 244554
·
Received October 14, 1999
Report
- Report Number
- 1056436-1999-00175
- Event Type
- Injury
- Date Received
- October 14, 1999
- Date of Event
- September 23, 1999
- Report Date
- September 24, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IN 1999, THE FACILITY'S HEAD NURSE INFORMED THE MANUFACTURER'S (MFR.) SALES REP OF THE FOLLOWING: LEAKAGE WAS REPORTED FROM THE DEVICE AND AS A RESULT, THE DEVICE WAS EXPLANTED. ON 10/01/1999, THE FACILITY'S HEAD NURSE PROVIDED THE MFR'S REP WITH THE FOLLOWING INFO: THE PHYSICIAN STATED THAT A DYE STUDY DEMONSTRATED THE DEVICE WAS LEAKING AT THE JUNCTION OF THE CATHETER AND DEVICE BODY. HE THOUGHT IT MAY HAVE BEEN INTRODUCED BY A BLUNT NEEDLE. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM Implant | VASCULAR ACCESS DEVICE | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | 14702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |