FDA Adverse Event
Malfunction
Summary report: N
HICKMAN TRIFUSION 19CM STRAIGHT KIT WITH INTERMEDIATE KIT
MDR report key: 3123632
·
Received May 15, 2013
Report
- Report Number
- 3006260740-2013-00229
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Date of Event
- December 14, 2011
- Report Date
- April 26, 2013
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K041088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REVE1099 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214947 | HICKMAN TRIFUSION 19CM STRAIGHT KIT WITH INTERMEDIATE KIT | LJS | C. R. BARD INC. (BASD) | REVE1099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |