FDA Adverse Event
Injury
Summary report: N
HICKMAN 7F DUAL-LUMEN CV CATHETER
MDR report key: 3811173
·
Received March 10, 2014
Report
- Report Number
- MW5036069
- Event Type
- Injury
- Date Received
- March 10, 2014
- Date of Event
- February 11, 2014
- Report Date
- February 19, 2014
- Manufacturer
- BARD ACCESS SYSTEM, INC.
- Product Code
- LJT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013, PT HAD A 7 FRENCH HICKMAN DUAL-LUMEN TUNNELED CENTRAL VENOUS CATHETER PLACED. ON (B)(6) 2014, THE CATHETER WAS REMOVED. THE CATHETER BROKE DURING THE ATTEMPTED REMOVAL. A SECOND DERMOTOMY WAS REQ'D TO REMOVE TUNNELED CATHETER AS IT HAD BECOME SIGNIFICANTLY SCARRED IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143616 | HICKMAN 7F DUAL-LUMEN CV CATHETER | NONE | LJT | BARD ACCESS SYSTEM, INC. | 0600570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |