Brand Name | CLEARLINK LUER ACTIVATED VALVE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE CORPORATION |
deerfield IL |
|
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 | 9595702 |
MDR Text Key | 175221911 |
Report Number | 1416980-2020-00058 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112893 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
01/16/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/16/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 2C8401S |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/20/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | SPECTRUM INFUSION PUMP |