MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-07 for INTRAVIA CONTAINER EMPTY 2B8011 manufactured by Baxter Healthcare Corporation.
[178206589]
Seven (7) devices were received for evaluation. The containers were inspected in a lighted inspection booth via the tyndall illumination to aid in the observation of visible particulates. The particles were consistent with a particle caused by a gouge on the side of the medication port tube (needle strike). The reported condition was verified. The cause of the condition was due to multiple needle strikes. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[178206590]
During product evaluation, seven (7) intravia containers were observed to have particulate inside the fluid pathway. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-00478 |
| MDR Report Key | 9683201 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-06-25 |
| Date Added to Maude | 2020-02-07 |
| 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 | 2020-02-07 |
| Model Number | NA |
| Catalog Number | 2B8011 |
| Lot Number | DR19F24014 |
| Device Availability | N |
| 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 | 2020-02-07 |