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.
[178206795]
Thirteen devices were received for evaluation. The container was inspected in a lighted inspection booth via the tyndall illumination to aid in the observation of visible particulates. Six of the containers had particles that 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. The other seven devices the particulate was verified; however, the cause of the condition could not be determined. 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
[178206796]
During product evaluation, thirteen (13) 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 | 1416980-2020-00477 |
| MDR Report Key | 9683217 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-06-24 |
| 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 | DR19F22018 |
| Device Availability | Y |
| 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 |