FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 3-LUMEN 7 FR X 30 CM
MDR report key: 3960126
·
Received June 23, 2014
Report
- Report Number
- 9680794-2014-00121
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Date of Event
- June 17, 2014
- Report Date
- June 19, 2014
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE WARD THREE DAYS AFTER THE CATHETER WAS PLACED, A LEAK WAS FOUND FROM THE WHITE LUMEN DURING INJECTION. AS A RESULT, A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. A DELAY WAS REPORTED, HOWEVER, NO DEATH OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS OCCURRENCE. CEMMA CONFIRMED THAT THE CATHETER DID NOT TEAR BUT INSTEAD THE DOCTOR INTENTIONALLY CUT THE CATHETER FOR A BACTERIAL CULTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364873 | CVC SET: 3-LUMEN 7 FR X 30 CM | ADULT MULTI-LUMEN | DQY | ARROW INTERNATIONAL INC. | CF2103473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |