FDA Adverse Event
Malfunction
Summary report: N
HICKMAN 12 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCE
MDR report key: 3140306
·
Received May 24, 2013
Report
- Report Number
- 3006260740-2013-00251
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- March 24, 2013
- Report Date
- May 2, 2013
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K830233
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
PT HAD A TUNNELED HICKMAN CATHETER PLACED APPROX ONE MONTH AGO. SHE HAD ONE OF THE PORTS DEVELOP A LEAK BECAUSE OF USER ERROR BY FORCED INJECTION AGAINST THE CLOSED CLAMP. THEREFORE, THE CATHETER BECAME DAMAGED. WE WERE CONSULTED FOR REPLACEMENT OF THE CATHETER AND THE CATHETER WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232244 | HICKMAN 12 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCE | LJS | C. R. BARD INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |