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 - DOMINICAN REPUBLIC |
carretera sanchez km 18.5 |
parque industrial itabo, piisa |
haina, san cristobal 91000 |
DR
91000
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL
|
2242702068
|
|
MDR Report Key | 15695688 |
MDR Text Key | 304327685 |
Report Number | 1416980-2022-05861 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00085412656649 |
UDI-Public | (01)00085412656649 |
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 |
Health Professional,Company Representative |
Reporter Occupation |
Pharmacist
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
12/14/2022 |
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 | 2R8403 |
Device Lot Number | DR21H20031 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/05/2022 |
Initial Date FDA Received | 10/29/2022 |
Supplement Dates Manufacturer Received | 12/05/2022
|
Supplement Dates FDA Received | 12/14/2022
|
Date Device Manufactured | 08/21/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 9612052-06/30/22-001-R |
Patient Sequence Number | 1 |
Treatment | UNSPECIFIED DRUG |
|
|