FDA Adverse Event
Malfunction
Summary report: N
HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER
MDR report key: 3243225
·
Received July 19, 2013
Report
- Report Number
- 3006260740-2013-00357
- Event Type
- Malfunction
- Date Received
- July 19, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 27, 2013
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K830233
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, THE MFG LOT NUMBER WAS PROVIDED IS AN INVALID MFG LOT NUMBER.
Description of Event or Problem · 1
IT IS REPORTED THAT THE CATHETER WAS LEAKING. ADD'L INFO REQUESTED. CONSERVATIVELY REPORTED AS A SUBQ LEAK AT THIS TIME DUE TO LACK OF INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338238 | HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER | LJS | C. R. BARD INC. (BASD) | HUU600171 (INVALID) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |