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 2020-03-12 for INTRAVIA CONTAINER EMPTY 2J8002 manufactured by Baxter Healthcare Corporation.
[183142977]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183142978]
It was reported that there was particulate matter inside three (3) intravia container 250 ml capacity. The particulate was further described as a sliver of plastic. This issue was identified during setup and prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01367 |
| MDR Report Key | 9824354 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-12 |
| 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 - DOMINICAN REPUBLIC |
| Manufacturer Street | CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAVIA CONTAINER EMPTY |
| Generic Name | CONTAINER, I.V. |
| Product Code | KPE |
| Date Received | 2020-03-12 |
| Model Number | NA |
| Catalog Number | 2J8002 |
| Lot Number | DR19B28030 |
| 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 | 2020-03-12 |