MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for VASCULAR PROBES 7151015ES manufactured by Baxter Healthcare - Saint Paul.
[125622540]
The device was received for evaluation. The returned unit was labeled for singe use. Visual inspection revealed particulate matter on the outside wall of the inner pouch. Microscopic inspection revealed that the particulate matter was a fiber. The size of the particulate matter was found to be within specification for this device. The device was found to be conforming product. 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
[125622542]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-06883 |
| MDR Report Key | 8014905 |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-29 |
| Date Mfgr Received | 2018-09-30 |
| Date Added to Maude | 2018-10-29 |
| 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 - SAINT PAUL |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | SAINT PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VASCULAR PROBES |
| Generic Name | DILATOR, VESSEL, SURGICAL |
| Product Code | DWP |
| Date Received | 2018-10-29 |
| Model Number | NA |
| Catalog Number | 7151015ES |
| Lot Number | SP18D031298565 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - SAINT PAUL |
| Manufacturer Address | SAINT PAUL MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |