MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-24 for MINIBAG PLUS CONTAINER 2C4950 manufactured by Baxter Healthcare Corporation.
[176256520]
Common device name: equipment, laboratory, general purpose, labeled or promoted for a specific medical use. (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[176256521]
It was reported that three (3) mini-bag plus container/vial docking tools were observed to be damaged. The damage was further reported as? Rusted gears on the underside of the device;? ? The gears that causes the handles to compress and decompress.? The reporter stated that the device was still functional. This issue was identified prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-07647 |
| MDR Report Key | 9627444 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-24 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-09 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 - CLEVELAND |
| Manufacturer Street | 911 HIGHWAY 61 NORTH PO BOX 1058 |
| Manufacturer City | CLEVELAND MS 38732 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38732 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINIBAG PLUS CONTAINER |
| Generic Name | SEE H10 |
| Product Code | LXG |
| Date Received | 2020-01-24 |
| Model Number | NA |
| Catalog Number | 2C4950 |
| Lot Number | ASKU |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |