FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 219276
·
Received April 19, 1999
Report
- Report Number
- 1056436-1999-00069
- Event Type
- Injury
- Date Received
- April 19, 1999
- Report Date
- March 22, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 03/22/1999, THE FACILITY'S BUYER INFORMED THE DISTRIBUTOR'S SALES REP OF THE FOLLOWING: THE DEVICE CATHETER HAD A FRACTURE OR CUT. ON 03/22/1999, THE MFR'S (MFR) REP CONTACTED THE FACILITY'S BUYER FOR ADD'L INFO (I.E., LOT NUMBER OF THE DEVICE ETC.) REGARDING THIS EVENT; HOWEVER, SHE STATED THAT SHE HAS NO WAY OF KNOWING THE LOT NUMBER. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM | VASCULAR ACCESS DEVICE | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |