FDA Adverse Event
Malfunction
Summary report: N
CVC KIT: 3-LUMEN 12 FR X 20CM
MDR report key: 3250429
·
Received July 24, 2013
Report
- Report Number
- 1036844-2013-00245
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Date of Event
- June 4, 2013
- Report Date
- July 2, 2013
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQO
- PMA / PMN Number
- K970864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT IS REPORTED THAT AFTER 15 DAYS OF PLACEMENT, THERE WAS BLOOD LEAKAGE FROM THE HUB OF THE DISTAL EXTENSION LINE. THE USER CLAMPED THE DISTAL EXTENSION LINE AND USED THE MEDICAL EXTENSION LINE INSTEAD TO INJECT VASOPRESSOR. ONE DAY AFTER SWITCHING THE EXTENSION LINE, THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED. THE PATIENT SUFFERED FROM (B)(6) AND THE SAMPLE WAS DISINFECTED AT THE HOSPITAL USING HYPOCHLOROUS ACID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344687 | CVC KIT: 3-LUMEN 12 FR X 20CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQO | ARROW INTL., INC. | RF1082369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |