MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-10-18 for COSEAL 934071 manufactured by Baxter Healthcare - Hayward.
[90417437]
The date of the event was reported as? A month ago?. (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[90417438]
It was reported the coseal device contained particulate matter. When the coseal package was opened,? Black floaty fibers? Were observed in the solution. It was also reported that the particulate was not part of the rubber from the syringe. There was no patient involvement and the product was not used. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[104423288]
The device was received for evaluation. A visual inspection was performed and black fiber was observed inside the transfer port. The reported condition was verified. The black fiber stated in this complaint was sent to an outside contract lab for identification. According the report, a dark inclusion within a white flake was analyzed using fournier transform infrared spectroscopy (ftir) and was found to be a polyamide best batching a nylon 6 and a second material, possibly a carboxylic acid. The cause was determined to be a manufacturing defect. A nonconformance has been opened to address this issue. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. In addition, 12 retention samples were evaluated with no issues noted. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2017-08379 |
| MDR Report Key | 6958427 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-10-18 |
| Date of Report | 2017-11-15 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-10-18 |
| 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 | COSEAL |
| Generic Name | SEALANT,POLYMERIZING |
| Product Code | NBE |
| Date Received | 2017-10-18 |
| Returned To Mfg | 2017-10-17 |
| Model Number | NA |
| Catalog Number | 934071 |
| Lot Number | HA170229 |
| ID Number | NA |
| Device Expiration Date | 2017-08-31 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Address | HAYWARD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-18 |