Brand Name | ARROW HEMODIALYSIS KIT: 2-L 14 FR X 25 CM ANTI |
Type of Device | CATHETER, HEMODIALYSIS, NON-IMPL. |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
MDR Report Key | 7510953 |
MDR Text Key | 108154758 |
Report Number | 1036844-2018-00135 |
Device Sequence Number | 1 |
Product Code |
MPB
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Type of Report
| Initial,Followup |
Report Date |
05/02/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/14/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2018 |
Device Catalogue Number | CDC-26142-X1A |
Device Lot Number | 23F17C0827 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 06/13/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|