FDA Adverse Event
Injury
Summary report: N
5 FR. S/L POWERPICC - NURSING FULL TRAY WITH MI, SHERLOCK TLS
MDR report key: 1772207
·
Received July 22, 2010
Report
- Report Number
- 3006260740-2010-00204
- Event Type
- Injury
- Date Received
- July 22, 2010
- Date of Event
- October 26, 2009
- Report Date
- July 12, 2010
- Manufacturer
- C. R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K063240
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.
Description of Event or Problem · 1
AFTER FLUSH, PT HAD THE FOLLOWING SYMPTOM: FACIAL FLUSHING, FEELING FAINT. THE SYMPTOMS HAD BEEN RESOLVED AFTER 5 MINUTES. NO TREATMENT RENDERED. PICC LINE LEFT IN PLACE FOR 38 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5 FR. S/L POWERPICC - NURSING FULL TRAY WITH MI, SHERLOCK TLS | LJS | C. R. BARD, INC. (BASD) | RETG0970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |