FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 329044
·
Received April 26, 2001
Report
- Report Number
- 1056436-2001-00056
- Event Type
- Injury
- Date Received
- April 26, 2001
- Date of Event
- March 26, 2001
- Report Date
- April 26, 2001
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IN 03/2001, THE USER FACILITIES RN INFORMED THE MFR'S REP VIA TELEPHONE OF THE FOLLOWING: DEVICE EVENT, POSSIBLE "PINCH-OFF". IN 04/2001, THE MFR RECEIVED A MEDWATCH REPORT (UF #17C00011024-2001-0003) VIA FAX THAT STATES THE FOLLOWING: PT PRESENTED FOR CHEMO IN 03/2001, UNABLE TO ASPIRATE BLOOD AND PAINFUL TO FLUSH. CHEST X-RAY SHOWS PARTIAL TEAR OF DEVICE JUST UNDER CLAVICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19236 | LIFEPORT VASCULAR ACCESS SYSTEM | VASCULAR ACCESS DEVICE | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | 15228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |