Brand Name | SMITHS MEDICAL SWIVEL CONNECTOR REUSABLE 15MM |
Type of Device | CONNECTOR, AIRWAY (EXTENSION) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL, ASD INC. MHYT |
boundary road |
|
kent, hythe |
UK
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 8510829 |
MDR Text Key | 141813101 |
Report Number | 3012307300-2019-01971 |
Device Sequence Number | 1 |
Product Code |
BZA
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/12/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 02/28/2023 |
Device Catalogue Number | 100/250/001 |
Device Lot Number | 3565230 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/15/2019 |
Date Manufacturer Received | 03/12/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/19/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|