Brand Name | ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM |
Type of Device | CATHETER, HEMODIALYSIS, IMPLA |
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 |
victoria
sandlin
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 11151467 |
MDR Text Key | 226316197 |
Report Number | 9680794-2021-00020 |
Device Sequence Number | 1 |
Product Code |
MSD
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K111117 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/18/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/11/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 05/31/2023 |
Device Catalogue Number | CS-15242-VSP |
Device Lot Number | 13F20F0025 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/18/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/02/2020 |
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 |