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 2020-03-31 for 2000 ML TPN BAG H938740 manufactured by Baxter Healthcare Corporation.
[185737022]
(b)(6). The device was manufactured at one of the following manufacturing locations: availmed (b)(4) or baxter healthcare - englewood (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[185737023]
It was reported that a 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from the infusion port. The bag was filled with chemotherapy drugs. This was detected in the dispensing room before treatment, prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01873 |
| MDR Report Key | 9904154 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-31 |
| 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 | PHARMACIST |
| 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 | SEE H10 |
| Manufacturer Street | SEE H10 SEE H10 |
| Manufacturer City | SEE H10 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2000 ML TPN BAG |
| Generic Name | SET, I.V. FLUID TRANSFER |
| Product Code | LHI |
| Date Received | 2020-03-31 |
| Model Number | NA |
| Catalog Number | H938740 |
| Lot Number | ASKU |
| Device Availability | N |
| 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 | 2020-03-31 |