Brand Name | INTERLINK SYSTEM T-CONNECTOR EXTENSION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BAXTER HEALTHCARE - AIBONITO |
aibonito |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - AIBONITO |
rd 721 km 0 3 po box 1389 |
ni |
aibonito |
|
Manufacturer Contact |
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 5997316 |
MDR Text Key | 56389863 |
Report Number | 1416980-2016-15905 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K921899 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
11/07/2016 |
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 Expiration Date | 04/30/2021 |
Device Catalogue Number | 2N3339 |
Device Lot Number | UR16D30027 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/07/2016 |
Initial Date FDA Received | 10/04/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 11/07/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/12/2016 |
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 | (B)(4); UNSPECIFIED TUBING |
Patient Outcome(s) |
Other;
|