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 2020-03-30 for DUO-VENT CLEARLINK LUER ACTIVATED VALVE 2C8875 manufactured by Baxter Healthcare Corporation.
[185540436]
(b)(4). The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185540437]
It was reported that the tubing of a clearlink system solution set was leaked at the white junction. This was identified during patient infusion of unspecified "anti-reject" drug. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01826 |
| MDR Report Key | 9898150 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 - CARTAGO |
| Manufacturer Street | SEE H10 SEE H10 |
| Manufacturer City | CARTAGO 30106 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 30106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUO-VENT CLEARLINK LUER ACTIVATED VALVE |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-19 |
| Model Number | NA |
| Catalog Number | 2C8875 |
| Lot Number | R19J08036 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |