FDA Adverse Event
Death
Summary report: N
PI CVC KIT: 3-L 7 FR X 20 CM AGB
MDR report key: 5481400
·
Received March 4, 2016
Report
- Report Number
- 1036844-2016-00146
- Event Type
- Death
- Date Received
- March 4, 2016
- Date of Event
- January 28, 2016
- Report Date
- February 4, 2016
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- FOZ
- PMA / PMN Number
- K071538
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT IS FOR THE THRID IN A SERIES CONSECUTIVE PRODUCT ISSUES WITH THE SAME PATIENT. THE FIRST TWO EVENTS WERE REPORTED UNDER MDR#S 1036844-2016-00144 AND 1036844-2016-00145. NO SAMPLE WILL BE RETURNED FOR EVALUAITON FOR THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO A PATIENT DURING A CODE SITUATION. WHEN TRYING TO GAIN ACCESS THE GUIDE WIRE KINKED. THE PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137403 | PI CVC KIT: 3-L 7 FR X 20 CM AGB | ARROWG+ARD CATHETER PRODUCTS | FOZ | ARROW INTERNATIONAL INC. | 23F15G1368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death |