FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 3-LUMEN 7 FR X 24 (60 CM)
MDR report key: 2150539
·
Received June 22, 2011
Report
- Report Number
- 1036844-2011-00199
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 17, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- FOZ
- PMA / PMN Number
- K862056
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT HOURS AFTER THE CATHETER WAS INDWELLED, A LEAK WAS FOUND NEAR THE JUNCTURE HUB IN THE PT'S ROOM. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED IN THE PT'S FEMORAL VEIN. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC KIT: 3-LUMEN 7 FR X 24 (60 CM) | ADULT MULTI-LUMEN CATHETER PRODUCTS | FOZ | ARROW INTL., INC. | RF0061790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |