Brand Name | CLEARLINK DUO-VENT SECONDARY MEDICATION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE - SINGAPORE |
singapore |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - SINGAPORE |
2 woodlands industrial park d |
|
singapore 73875 0 |
SN
738750
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 6825292 |
MDR Text Key | 83844014 |
Report Number | 1416980-2017-06979 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K961225 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
09/28/2017 |
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 |
Other
|
Device Expiration Date | 04/30/2022 |
Device Catalogue Number | 2C7462 |
Device Lot Number | SR17D05061 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/03/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/03/2017 |
Initial Date FDA Received | 08/28/2017 |
Supplement Dates Manufacturer Received | 09/03/2017
|
Supplement Dates FDA Received | 09/28/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |