FDA Adverse Event
Malfunction
Summary report: N
IMPLANTED CATHETER
MDR report key: 3943805
·
Received April 30, 2014
Report
- Report Number
- 3006260740-2014-00222
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- March 25, 2014
- Report Date
- April 10, 2014
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
PATIENT HAD PICC PLACED (B)(6) 2014. LATER DETERMINED DEVICE LEAKED. DEVICE REPLACED (B)(6) 2014 AND FOUND TO HAVE SMALL HOLE IN LINE. UNABLE TO DETERMINE IF PRODUCT DEFECT OR WEAR OF DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258476 | IMPLANTED CATHETER | CATHETER INTRAVASCULAR GREATER | LJS | C.R. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |