Brand Name | SET, ADMIN, CADD, 108", SPIKE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis, mn |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
|
minneapolis, mn |
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, mn
|
3833310
|
|
MDR Report Key | 9908427 |
MDR Text Key | 185903599 |
Report Number | 3012307300-2020-02406 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586027536 |
UDI-Public | 10610586027536 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K040636 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/31/2020 |
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 |
No Information
|
Device Expiration Date | 02/09/2023 |
Device Model Number | 21-7394-24 |
Device Lot Number | 48X091 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/02/2020 |
Initial Date FDA Received | 03/31/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/27/2018 |
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 Age | 18 YR |
Patient Weight | 96 |
|
|