Brand Name | ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" |
Type of Device | CATHETER,INTRAVASCULAR,THERAP |
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 | 6861158 |
MDR Text Key | 86091624 |
Report Number | 3003737899-2017-00109 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K071538 |
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 |
08/30/2017 |
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 |
Health Professional
|
Device Expiration Date | 11/30/2018 |
Device Catalogue Number | CDC-45703-PB1A |
Device Lot Number | 13F17E0048 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/30/2017 |
Initial Date FDA Received | 09/13/2017 |
Supplement Dates Manufacturer Received | 10/17/2017
|
Supplement Dates FDA Received | 10/23/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/04/2017 |
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 |