Brand Name | ARROW PSI SET: 8.5 FR |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
Manufacturer (Section G) |
ARROW INTERNATIONAL CR, A.S. |
jamska 2359/47 |
|
zdar nad sazavou 591 0 1 |
EZ
591 01
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334854
|
|
MDR Report Key | 7544778 |
MDR Text Key | 109268029 |
Report Number | 3006425876-2018-00342 |
Device Sequence Number | 1 |
Product Code |
DYB
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
05/14/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/25/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 02/28/2022 |
Device Catalogue Number | SI-09875-E |
Device Lot Number | 71F17L3016 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/29/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/28/2017 |
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 |
|
|