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 - AIBONITO |
rd 721 km 0 3 po box 1389 |
|
aibonito 00705 |
*
00705
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 18497778 |
MDR Text Key | 333103820 |
Report Number | 1416980-2024-00038 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K112893 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/11/2024 |
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 Catalogue Number | 2N8378 |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/18/2023
|
Initial Date FDA Received | 01/11/2024 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | CLEARLINK IV ACCESS VALVE SET. |