Brand Name | AMBULATORY INFUSION PUMPS CADD ADMINISTRATION SETS - FLOW STOP |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL ASD,INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD,INC. |
6000 nathan lane |
|
minneapolis MN 55442 |
|
Manufacturer Contact |
dave
halverson
|
6000 lane n |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 11403472 |
MDR Text Key | 239349908 |
Report Number | 3012307300-2021-01673 |
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 |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/03/2021 |
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 Model Number | SET, ADMIN, CADD, 108", SPIKE, 0.2 MICRON, FLTR, |
Device Catalogue Number | 21-7394-24 |
Device Lot Number | 4063438 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/03/2021 |
Initial Date FDA Received | 03/03/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/02/2020 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|