| Brand Name | ARROW CVC KIT: 16 GA X 8" |
|---|
| Type of Device | CATHETER INTRAVASCULAR THERAPE |
|---|
| Manufacturer (Section D) |
| ARROW INTERNATIONAL INC. |
| reading PA |
|
|---|
| Manufacturer (Section G) |
| ARROW INTERNATIONAL DE MEXICO S.A. DE C.V. |
| ave. washington 3701 |
| colonia panamericana, chihuahua |
| chihuahua 31200 |
|
MX
31200
|
|
|---|
| Manufacturer Contact |
|
katharine
tarpley
|
| 3015 carrington mill blvd |
| morrisville, NC 27560
|
|
|---|
| MDR Report Key | 11177182 |
|---|
| MDR Text Key | 227027316 |
|---|
| Report Number | 9680794-2021-00031 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code |
FOZ
|
| Combination Product (y/n) | N |
|---|
| Reporter Country Code | CH |
|---|
| PMA/PMN Number | K900263 |
|---|
| Number of Events Reported | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Report Source |
Manufacturer
|
|---|
| Source Type |
company representative,distri |
|---|
| Reporter Occupation |
|
|---|
| Type of Report
| Initial,Followup |
|---|
| Report Date |
12/29/2020 |
|---|
| 1 Device was Involved in the Event |
|
| 0 Patients were Involved in the Event: |
|
|---|
| Date FDA Received | 01/15/2021 |
|---|
| Is this an Adverse Event Report? |
No
|
|---|
| Is this a Product Problem Report? |
Yes
|
|---|
| Device Operator |
|
|---|
| Device Expiration Date | 02/28/2021 |
|---|
| Device Catalogue Number | CA-24301 |
|---|
| Device Lot Number | 13F19H0373 |
|---|
| Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
|---|
| Date Returned to Manufacturer | 01/20/2021 |
|---|
| Is the Reporter a Health Professional? |
No
|
|---|
| Was the Report Sent to FDA? |
|
|---|
| Event Location |
No Information
|
|---|
| Date Manufacturer Received | 02/09/2021 |
|---|
| Was Device Evaluated by Manufacturer? |
Yes
|
|---|
| Date Device Manufactured | 08/20/2019 |
|---|
| Is the Device Single Use? |
Yes
|
|---|
| Is This a Reprocessed and Reused Single-Use Device? |
No
|
|---|
| Type of Device Usage |
Initial
|
|---|
