Brand Name | MONITORING KIT W/ NEEDLELESS VALVE |
Type of Device | MONITORING KIT W/ NEEDLELESS VALVE |
Manufacturer (Section D) |
ICU MEDICAL, INC. |
4455 atherton dr. |
salt lake city UT 84123 |
|
Manufacturer (Section G) |
ICU MEDICAL, INC. |
4455 atherton dr. |
|
salt lake city UT 84123 |
|
Manufacturer Contact |
terry
scesny
|
4455 atherton drive |
salt lake city, UT 84123
|
8012641400
|
|
MDR Report Key | 5823001 |
MDR Text Key | 50516594 |
Report Number | 2025816-2016-00055 |
Device Sequence Number | 1 |
Product Code |
DRS
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K061573 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
04/08/2016 |
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 | 07/01/2018 |
Device Model Number | 011-46105-57 |
Device Catalogue Number | 011-46105-57 |
Device Lot Number | 3075214 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/14/2016 |
Is the Reporter a Health Professional? |
Yes
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
04/08/2016
|
Initial Date FDA Received | 07/26/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/19/2015 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |