Brand Name | TRANSPAC IV MTG. KIT W/SAFESET |
Type of Device | TRANSPAC IV MTG. KIT |
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 | 6028711 |
MDR Text Key | 57443046 |
Report Number | 2025816-2016-00165 |
Device Sequence Number | 1 |
Product Code |
DRS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061573 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/09/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/13/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/01/2019 |
Device Model Number | 42646-06 |
Device Catalogue Number | 42646-06 |
Device Lot Number | 3261710 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/08/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/13/2016 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |