MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-23 for 1000 ML TPN BAG H938739 manufactured by Baxter Healthcare Corporation.
[184544941]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184544942]
It was reported that a foreign material (black particle) was observed in seven (7) 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags. The location of the foreign material was unspecified. 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 | 1416980-2020-01655 |
| MDR Report Key | 9868282 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-23 |
| 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 | 1000 ML TPN BAG |
| Generic Name | SET, I.V. FLUID TRANSFER |
| Product Code | LHI |
| Date Received | 2020-03-23 |
| Model Number | NA |
| Catalog Number | H938739 |
| Lot Number | 60195768 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-23 |