FDA Adverse Event
Injury
Summary report: N
GROSHONG NXT CLEARVUE 4 FR SL PICC NURSING BASIC TRAY
MDR report key: 1850838
·
Received September 28, 2010
Report
- Report Number
- 3006260740-2010-00275
- Event Type
- Injury
- Date Received
- September 28, 2010
- Date of Event
- August 26, 2010
- Report Date
- September 14, 2010
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K034020
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVAL. A CHR REVIEW SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT (288615).
Description of Event or Problem · 1
LAST WEEK (JULY 9TH) WE WERE CONTACTED BY THE ONCOLOGY AMBULATORY SERVICES AT (B)(4)HOSPITAL IN (B)(4). PT 12: 3 TREATMENTS WITH TAXOTERE, ONE WITH 5FU, EPIRUBICIN AND SENDOXAN. THROMBOSIS DIAGNOSED AUGUST 26.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GROSHONG NXT CLEARVUE 4 FR SL PICC NURSING BASIC TRAY | LJS | C. R. BARD INC. (BASD) | REUB0759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |