MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for PORTEX EPIDURAL FILTER, FLAT WITH LUER LOCK 100/386/010 manufactured by Smiths Medical Asd, Inc..
| Report Number | 3012307300-2019-02847 |
| MDR Report Key | 8755048 |
| Date Received | 2019-07-02 |
| Date of Report | 2019-09-19 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2019-07-02 |
| 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 Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL NORTH AMERICA |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 034310724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 034310724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORTEX EPIDURAL FILTER, FLAT WITH LUER LOCK |
| Generic Name | FILTER, CONDUCTION, ANESTHETIC |
| Product Code | BSN |
| Date Received | 2019-07-02 |
| Returned To Mfg | 2019-06-11 |
| Model Number | 100/386/010 |
| Catalog Number | 100/386/010 |
| Lot Number | 3633743 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-02 |