FDA Adverse Event
Malfunction
Summary report: N
ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
MDR report key: 9886229
·
Received March 26, 2020
Report
- Report Number
- 3006425876-2020-00301
- Event Type
- Malfunction
- Date Received
- March 26, 2020
- Date of Event
- February 11, 2020
- Report Date
- March 26, 2020
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- FOZ
- PMA / PMN Number
- K900263
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
QN#(B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATES THAT THE DILATOR REFERENCED IN MDR#3006425876-2020-00176 CAUSED DAMAGE TO THE SPRING WIRE GUIDE; THUS, IT WAS DETERMINED THAT ONLY ONE COMPLAINT IS NEEDED. PLEASE NOTE THAT THIS MDR WILL BE VOIDED. ALL INFORMATION FOR THIS COMPLAINT IS REFERENCED IN MDR# 3006425876-2020-00176.
Additional Manufacturer Narrative · 1
QN#: (B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE CUSTOMER REPORTS THAT THE SWG (SPRING WIRE GUIDE) KINKED DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349363 | ARROW CVC SET: 3-LUMEN 7 FR X 20 CM | CATHETER INTRAVASCULAR THERAPE | FOZ | ARROW INTERNATIONAL INC. | 71F19D1766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |