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 2020-03-17 for FLOSEAL 1503278 manufactured by Baxter Healthcare Corporation.
[183858210]
Two actual samples were received for evaluation. A visual inspection was performed under the microscope which revealed a reddish colored particulate matter in the needle syringe of the samples. The calcium chloride vial and the reddish pm inside the needle syringe were inspected under a microscope. The pm inside the needle syringe was of similar color, texture and shape as the missing segment from the calcium chloride vial stopper puncture site. The reported problem was verified. The cause of the particulate matter was found to be due to stopper coring; however the cause of coring was unable to 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
[183858211]
During evaluation a reddish colored particulate matter was observed in the needle syringe of two floseals. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01491 |
| MDR Report Key | 9845140 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-17 |
| 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 - HAYWARD |
| Manufacturer Street | 2024 W WINTON AVE |
| Manufacturer City | HAYWARD CA 94545 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOSEAL |
| Generic Name | AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED |
| Product Code | LMF |
| Date Received | 2020-03-17 |
| Model Number | NA |
| Catalog Number | 1503278 |
| Lot Number | HA190885 |
| 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 | 2020-03-17 |