MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-24 for 2000 ML TPN BAG H938740 manufactured by Baxter Healthcare Corporation.
[184639648]
The device was received and is currently awaiting evaluation completion. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184639649]
It was reported that an unspecified quantity of 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked "into the triangle in the corner of the bag during compounding. " there was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[188472118]
Additional information was added: correction: the actual device was not returned to the manufacturer. The lot was manufactured from october 16, 2019 - october 17, 2019. The actual device was not available; however, two (2) companion samples were received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Functional testing was performed with tap water on both samples and no leaks were observed on either device. The reported condition was not verified. 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
| Report Number | 1416980-2020-01662 |
| MDR Report Key | 9871375 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| 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 | AVAILMED |
| Manufacturer Street | C. INDUSTRIAL LT. 001 MZ. 105 NO 20905 INT A, COL CD IND. |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| 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 | 2020-03-24 |
| Returned To Mfg | 2020-03-02 |
| Model Number | NA |
| Catalog Number | H938740 |
| Lot Number | 60210019 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |