MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-03 for CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET FNC3220N manufactured by Baxter Healthcare Corporation.
[181922988]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[181922989]
It was reported that the tubing of a continu-flo blood/solution set was cut near the y-site of the clearlink. The cut tubing was discovered in the packaging prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1416980-2020-01158 |
MDR Report Key | 9782421 |
Report Source | COMPANY REPRESENTATIVE,CONSUM |
Date Received | 2020-03-03 |
Date of Report | 2020-04-02 |
Date of Event | 2020-02-06 |
Date Mfgr Received | 2020-03-30 |
Device Manufacturer Date | 2019-08-02 |
Date Added to Maude | 2020-03-03 |
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 - TUNISIA |
Manufacturer Street | ROUTE DE CHEBBAOU 2021OUED E |
Manufacturer City | TUNIS |
Manufacturer Country | TS |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET |
Generic Name | SET, BLOOD TRANSFUSION |
Product Code | BRZ |
Date Received | 2020-03-03 |
Returned To Mfg | 2020-03-04 |
Model Number | NA |
Catalog Number | FNC3220N |
Lot Number | 19H09T433 |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BAXTER HEALTHCARE CORPORATION |
Manufacturer Address | DEERFIELD IL |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-03 |