MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-29 for COSEAL 934073 manufactured by Baxter Healthcare - Hayward.
[125603587]
The device was received for evaluation in its unopened pouch. The returned device was labeled for single use. Visual inspection revealed white powder scattered inside the pouch of the dsd syringe. A concentrated area of white powder was observed at the transfer port of the dsd syringe. The reported condition was verified. The cause of the condition was not 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
[125603588]
This report summarizes 1 malfunction events. It was reported that white particulate matter was found inside the transfer port of a coseal surgical sealant product. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-06907 |
| MDR Report Key | 8015802 |
| 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 - 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 | 0 |
| Brand Name | COSEAL |
| Generic Name | SEALANT,POLYMERIZING |
| Product Code | NBE |
| Date Received | 2018-10-29 |
| Model Number | NA |
| Catalog Number | 934073 |
| Lot Number | HA170722CC |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Address | HAYWARD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |