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 2020-02-19 for ALL-IN-ONE CONTAINER E3MC3802 manufactured by Baxter Healthcare Corporation.
[180025760]
This event occurred during the unspecified date of (b)(6) 2020. (b)(6). The actual sample was received for evaluation. A visual inspection was performed and a black embedded particle was present in the face of the bag. The reported condition was verified. The cause of the condition was due to a manufacturing related issue. This issue is being further investigated. 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
[180025761]
It was reported that a particulate matter was observed within the wall of the all-in-one container. This was observed after filling. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-00794 |
| MDR Report Key | 9728137 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2018-11-15 |
| Date Added to Maude | 2020-02-19 |
| 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 - MALTA |
| Manufacturer Street | A47 INDUSTRIAL ESTATE |
| Manufacturer City | MARSA |
| Manufacturer Country | MT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-IN-ONE CONTAINER |
| Generic Name | CONTAINER, I.V. |
| Product Code | KPE |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-02-06 |
| Model Number | NA |
| Catalog Number | E3MC3802 |
| Lot Number | 181222V494 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |