Brand Name | ARROW CVC SET: 3-LUMEN 7 FR X 20 CM |
Type of Device | CATHETER PERCUTANEOUS |
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 | 10345108 |
MDR Text Key | 201612146 |
Report Number | 3006425876-2020-00661 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (Y/N) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K862056 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
07/16/2020 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 07/30/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | IPN030885 |
Device Catalogue Number | CV-15703 |
Device LOT Number | 71F19H0305 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 09/02/2020 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 10/16/2020 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 08/08/2019 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|