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 2019-10-15 for CARTRIDGE 101025 manufactured by Baxter Healthcare - Tijuana Baja.
| Report Number | 8030638-2019-00015 |
| MDR Report Key | 9194442 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-15 |
| Date of Report | 2019-11-11 |
| Date of Event | 2019-09-20 |
| Date Facility Aware | 2019-09-20 |
| Report Date | 2019-10-15 |
| Date Reported to FDA | 2019-10-15 |
| Date Reported to Mfgr | 2019-10-15 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2019-03-04 |
| Date Added to Maude | 2019-10-15 |
| 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 - TIJUANA BAJA |
| Manufacturer Street | BLVD PACIFICO 10014 PARQUE INDUSTRIAL PACIFICO |
| Manufacturer City | TIJUANA BAJA CALIFORNIA CP 22643 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 22643 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARTRIDGE |
| Generic Name | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE |
| Product Code | FJK |
| Date Received | 2019-10-15 |
| Returned To Mfg | 2019-10-03 |
| Model Number | NA |
| Catalog Number | 101025 |
| Lot Number | 1000218866 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - TIJUANA BAJA |
| Manufacturer Address | TIJUANA BAJA CALIFORNIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-15 |