Brand Name | CVC SET: 2-LUMEN 8 FR X 16 CM |
Type of Device | ADULT MULTI LUMEN CATHETER PRODUCTS |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
Manufacturer (Section G) |
ARROW INTERNATIONAL CR, A.S. |
jamska 2359/47 |
|
zdar nad sazavou 591 01 |
EZ
591 01
|
|
Manufacturer Contact |
john
george
|
2400 bernville road |
reading, PA 19605
|
6103780131
|
|
MDR Report Key | 4860007 |
MDR Text Key | 5848070 |
Report Number | 3006425876-2015-00207 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K862056 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
06/11/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/31/2019 |
Device Catalogue Number | CS-12802 |
Device Lot Number | 71F15B1477 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/06/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/29/2015 |
Initial Date FDA Received | 06/22/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/03/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/23/2015 |
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 |
Patient Outcome(s) |
Required Intervention;
|