Brand Name | CLEARLINK LUER ACTIVATED VALVE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE - DOMINICAN REPUBLIC |
haina san cristobal |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - DOMINICAN REPUBLIC |
carretera sanchez km 18.5 |
parque industrial itabo, piisa |
haina san cristobal |
DR
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 6848879 |
MDR Text Key | 85142347 |
Report Number | 1416980-2017-07185 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K112893 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/16/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 2N8341 |
Device Lot Number | DR16K08037 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/05/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/15/2017
|
Initial Date FDA Received | 09/07/2017 |
Supplement Dates Manufacturer Received | 09/26/2017
|
Supplement Dates FDA Received | 10/16/2017
|
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 |
Treatment | CLEARLINK SOLUTION SET, 2H8480; DOUBLE LUMEN UVC (UNSPECIFIED); ONE-LINK DEVICE, 7N8399 |
Patient Outcome(s) |
Required Intervention;
|