Brand Name | EPIDURAL CATHETERIZATION SET |
Type of Device | ANESTHESIA CONDUCTION 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 |
effie
jefferson
|
3015 carrington mill blvd |
morrisville 27560
|
9194332672
|
|
MDR Report Key | 9526856 |
MDR Text Key | 179444736 |
Report Number | 3006425876-2019-01100 |
Device Sequence Number | 1 |
Product Code |
BSO
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K140110 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/20/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/06/2021 |
Device Catalogue Number | JC-05400-E |
Device Lot Number | 71F19F0330 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/20/2019
|
Initial Date FDA Received | 12/27/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/10/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |