Brand Name | DUO-VENT CLEARLINK LUER ACTIVATED VALVE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE - SINGAPORE |
singapore |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - SINGAPORE |
2 woodlands industrial park d |
ni |
singapore |
SN
|
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 6048573 |
MDR Text Key | 58129161 |
Report Number | 1416980-2016-16544 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
11/08/2016 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | FNC3121 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/26/2016
|
Initial Date FDA Received | 10/21/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/08/2016
|
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 |
N
|
Patient Sequence Number | 1 |
Treatment | COLLEAGUE PUMP; COMPOUNDED SODIUM LACTATE (CSL); NON-BAXTER TRIPLE LUMEN EXTENSION SET; SYNTOCINON |
Patient Outcome(s) |
Required Intervention;
|