MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-10-07 for EVA BAG-500ML AZB8152 manufactured by Baxter Healthcare - Sao Paulo.
[1697594]
The customer reported to baxter (b)(4) an eva bag that presented a leak. The condition occurred during filling. There was no patient injury or medical intervention necessary. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[8770247]
(b)(4). The sample is not available for evaluation, therefore, the condition cannot be confirmed or duplicated and the assignable root cause could not be determined. The batch review was completed for the reported lot and no deviations were found. This device is manufactured for distribution outside of the united states (us); therefore, it does not contain a us 510k number. However, this mdr is being submitted because it is the same as or similar to a product distributed within the us.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000001-2010-03838 |
| MDR Report Key | 1860477 |
| Report Source | 01,05 |
| Date Received | 2010-10-07 |
| Date of Report | 2010-09-08 |
| Date of Event | 2010-08-31 |
| Date Mfgr Received | 2010-09-08 |
| Date Added to Maude | 2011-09-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE - SAO PAULO |
| Manufacturer Street | AV. ENGENHEIRO EUSEBIO STEVAUX |
| Manufacturer City | SAO PAULO |
| Manufacturer Country | BR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVA BAG-500ML |
| Generic Name | BAG, RESERVOIR |
| Product Code | BTC |
| Date Received | 2010-10-07 |
| Catalog Number | AZB8152 |
| Lot Number | PE28N1 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - SAO PAULO |
| Manufacturer Address | AV. ENGENHEIRO EUSEBIO STEVAUX SAO PAULO BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-07 |