FDA Adverse Event
Malfunction
Summary report: N
RA CATH SET: 20GA X 1-3/4
MDR report key: 3913011
·
Received May 14, 2014
Report
- Report Number
- 9680794-2014-00110
- Event Type
- Malfunction
- Date Received
- May 14, 2014
- Date of Event
- May 5, 2014
- Report Date
- May 5, 2014
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQX
- PMA / PMN Number
- K810675
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT'S RADIAL ARTERY IN THE OPERATING ROOM. WHILE ATTEMPTING TO ADVANCE THE SPRING WIRE GUIDE PAST THE NEEDLE, THE WIRE WENT THROUGH THE CLEAR PLASTIC TUBE CONTAINING IT. AS A RESULT, EVERYTHING WAS REMOVED AND A SECOND INSERTION WAS MADE USING A NEW KIT. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288128 | RA CATH SET: 20GA X 1-3/4 | ARTERIAL CATHETER PRODUCTS | DQX | ARROW INTERNATIONAL INC. | 14F13L0155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |