MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-09 for PREVELEAK ADS201808 manufactured by Baxter Healthcare ? Moutain View.
[123258794]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[123258797]
It was reported that one unit of preveleak contained particulate matter. This was further described as white particulates that were noted to be floating in the crosslinker solution when the product was taken out of the package. This was identified during use in a research laboratory setting in which the intended product use was to bond two pieces of peri-guard grafts. The product had been stored in a walk-in refrigerator before use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[126561871]
The actual device was not available; however, a photograph of the sample was provided for evaluation. Visual inspection of the photograph revealed that although the particulates were not readily visible, there was evidence that particulates were present in the solution. The reported problem was verified. 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
[126561872]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-06423 |
| MDR Report Key | 7947619 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-09 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-10-09 |
| 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 |
| Manufacturer Street | 835 MAUDE AVE |
| Manufacturer City | MOUNTAIN VIEW CA 94039 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94039 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREVELEAK |
| Generic Name | SEALANT, POLYMERIZING |
| Product Code | NBE |
| Date Received | 2018-10-09 |
| Model Number | NA |
| Catalog Number | ADS201808 |
| Lot Number | 70621001 |
| Device Expiration Date | 2019-06-21 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE ? MOUTAIN VIEW |
| Manufacturer Address | MOUNTAIN VIEW CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-09 |