MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-11 for N/A manufactured by Fresenius Kabi Usa, Llc.
| Report Number | 3002733956-2019-00002 |
| MDR Report Key | 8689884 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-06-11 |
| Date of Report | 2019-06-07 |
| Date Mfgr Received | 2019-05-16 |
| Date Added to Maude | 2019-06-11 |
| 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 | VIGILANCE COMPETENCE CENTER LZ THREE CORPORATE DRIVE |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8005517176 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | HEPARIN LOCK FLUSH |
| Product Code | NZW |
| Date Received | 2019-06-11 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS KABI USA, LLC |
| Manufacturer Address | VIGILANCE COMPETENCE CENTER LZ THREE CORPORATE DRIVE LAKE ZURICH IL 60047 US 60047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-11 |