FDA Adverse Event
Injury
Summary report: N
5 FR DL POWERPICC, NURSING FULL
MDR report key: 2792365
·
Received October 12, 2012
Report
- Report Number
- 3006260740-2012-00363
- Event Type
- Injury
- Date Received
- October 12, 2012
- Report Date
- May 18, 2009
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K051672
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A LOT HISTORY REVIEW (LHR) OF RERK0208 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
MEDICAL RECORD REVIEW FROM BARD DAVOL, INC. PT'S MEDICAL RECORDS INDICATED THAT PT HAD A PICC LINE PLACED ON (B)(6) 2008 AND DEVELOPED AN INFECTION. UNK REMOVAL DATE. LINE PLACEMENT IN RIGHT CEPHALIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5 FR DL POWERPICC, NURSING FULL | LJS | C. R. BARD INC. (BASD) | RERK0208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |