MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-27 for CLEARLINK BLOOD RECIPIENT SET FNC1173N manufactured by Baxter Healthcare Corporation.
Report Number | 1416980-2019-06607 |
MDR Report Key | 9386634 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-27 |
Date of Report | 2019-11-27 |
Date of Event | 2019-11-04 |
Date Mfgr Received | 2019-11-04 |
Device Manufacturer Date | 2018-11-28 |
Date Added to Maude | 2019-11-27 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
Manufacturer City | ROUND LAKE IL 60073 |
Manufacturer Country | US |
Manufacturer Postal | 60073 |
Manufacturer Phone | 2242702068 |
Manufacturer G1 | BAXTER HEALTHCARE - MALTA |
Manufacturer Street | A47 INDUSTRIAL ESTATE |
Manufacturer City | MARSA |
Manufacturer Country | MT |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CLEARLINK BLOOD RECIPIENT SET |
Generic Name | SET, BLOOD TRANSFUSION |
Product Code | BRZ |
Date Received | 2019-11-27 |
Model Number | NA |
Catalog Number | FNC1173N |
Lot Number | 18K28V539 |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BAXTER HEALTHCARE CORPORATION |
Manufacturer Address | DEERFIELD IL |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-27 |