Brand Name | ARROW CVC KIT: 2-LUMEN 7 FR X 16 CM |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
Manufacturer (Section G) |
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V |
ave. washington 3701, edificio 4 |
colonia complejo industrial, las americas |
chihuahua 31114 |
MX
31114
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334854
|
|
MDR Report Key | 6369200 |
MDR Text Key | 68763321 |
Report Number | 3003737899-2017-00016 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
02/20/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 04/29/2018 |
Device Catalogue Number | AK-42702-CDC |
Device Lot Number | 13F16H0225 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/20/2017 |
Initial Date FDA Received | 03/01/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/12/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/17/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |