FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 2-LUMEN 7 FR X 20 CM
MDR report key: 3904674
·
Received May 22, 2014
Report
- Report Number
- 3006425876-2014-00101
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Date of Event
- April 30, 2014
- Report Date
- May 5, 2014
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS EVENT OCCURRED IN THE ICU DURING INSERTION. THERE WAS DIFFICULTY ADVANCING THE DILATOR OVER THE SWG DURING INSERTION. UPON RETRACTION OF THE DILATOR, THE ANESTHESIOLOGIST FOUND THAT THE TIP OF THE DILATOR WAS DAMAGED. AS A RESULT, THE DILATOR WAS REMOVED AND A NEW KIT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A DELAY REPORTED, HOWEVER, THERE WAS NO HARM TO THE PATIENT. THERE WERE NO COMPLICATIONS, DEATH, OR INJURY REPORTED. MEDICAL INTERVENTIONS WAS NOT NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306579 | CVC SET: 2-LUMEN 7 FR X 20 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC. | 71F14A1356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |