FDA Adverse Event
Malfunction
Summary report: N
GROSHONG 8 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUC
MDR report key: 2012171
·
Received February 1, 2011
Report
- Report Number
- 3006260740-2011-00027
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- October 5, 2010
- Report Date
- January 7, 2011
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K831386
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
WHEN CONCLUDED THE CHEMOINFUSION, FOUND AN EDEMA NEAR THE ANTERIOR CHEST AREA CLOSE NEAR THE CVC INSERTION POINT. AFTER RX WITH CONTRAST MEDIA, THEY NOTED A LEAKAGE IN SUBCLAVIAN REGION NO PRESENCE OF CONTRAST MEDIA AT THE END OF THE CATHETER'S TIP. PROLONGED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GROSHONG 8 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUC | LJS | C. R. BARD INC. (BASD) | REUC0463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |