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 2019-12-19 for INTERLINK SYSTEM FNC1154 manufactured by Baxter Healthcare Corporation.
[172229582]
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[172229583]
It was reported that a foreign body was found inside of two (2) interlink system sets. This issue was identified before use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-07040 |
| MDR Report Key | 9500142 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2019-12-19 |
| 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 - SINGAPORE |
| Manufacturer Street | 2 WOODLANDS INDUSTRIAL PARK D |
| Manufacturer City | SINGAPORE 738750 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 738750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERLINK SYSTEM |
| Generic Name | SET, BLOOD TRANSFUSION |
| Product Code | BRZ |
| Date Received | 2019-12-19 |
| Returned To Mfg | 2020-02-19 |
| Model Number | NA |
| Catalog Number | FNC1154 |
| Lot Number | SR19G12083 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-12-19 |