FDA Adverse Event
Malfunction
Summary report: N
4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC K
MDR report key: 2160227
·
Received June 2, 2011
Report
- Report Number
- 3006260740-2011-00170
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- March 1, 2011
- Report Date
- May 11, 2011
- Manufacturer
- C. R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K034020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REUG1588 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. (B)(4).
Description of Event or Problem · 1
THE REPORTED COMPLAINT: AFTER THREE MONTHS FROM THE IMPLANT, THEY FOUND A HOLE NEAR 3 CM FROM THE EXIT SITE, INSIDE THE VEIN. PRODUCT REMOVED AND PLACED ANOTHER ONE. NO DAMAGES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC K | LJS | C. R. BARD, INC. (BASD) | REUG1588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |