Brand Name | PORTEX® SINGLE SHOT EPIDURAL TRAYS |
Type of Device | ANESTHESIA CONDUCTION KIT |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL NORTH AMERICA |
10 bowman drive |
|
keene NH 03431 0724 |
|
Manufacturer Contact |
lisa
perz
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833074
|
|
MDR Report Key | 6491541 |
MDR Text Key | 72808582 |
Report Number | 3012307300-2017-00905 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
UDI-Device Identifier | 20351688076134 |
UDI-Public | 20351688076134 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K965017 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/13/2017 |
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 | 05/31/2019 |
Device Catalogue Number | ACL10AT |
Device Lot Number | 3311323 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/17/2017 |
Initial Date FDA Received | 04/13/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/21/2016 |
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 |