FDA Adverse Event
Malfunction
Summary report: N
HICKMAN 10 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCE
MDR report key: 2062496
·
Received March 18, 2011
Report
- Report Number
- 3006260740-2011-00083
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 26, 2011
- Report Date
- March 15, 2011
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K830233
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT REMAINS IN USE. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem · 1
ONCOLOGY PT, (B)(6) INSERTED ON (B)(6). RUPTURED BLUE LUMEN ON (B)(6) WHILE IV TEAM NURSE WAS FLUSHING. NO CONTRAST STUDIES, LUMEN WAS REPAIRED AND LABELED NOT TO USE DUE TO POSSIBLE INFECTION RISK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HICKMAN 10 FR TRIPLE-LUMEN CV CATHETER, PEEL-APART INTRODUCE | LJS | C.R. BARD, INC. (BASD) | HUUF0259 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |