MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for CONECTR,STERILE RFA,LUER-ORAL 42703 manufactured by Baxter Healthcare - Round Lake.
[142883381]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[142883382]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-02125 |
| MDR Report Key | 8533721 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-07-26 |
| Date Mfgr Received | 2019-06-30 |
| Date Added to Maude | 2019-04-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 - ROUND LAKE |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60073 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONECTR,STERILE RFA,LUER-ORAL |
| Generic Name | DISPENSER, LIQUID MEDICATION |
| Product Code | KYX |
| Date Received | 2019-04-19 |
| Model Number | NA |
| Catalog Number | 42703 |
| Lot Number | 60132127 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - ROUND LAKE |
| Manufacturer Address | ROUND LAKE IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-19 |