MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-15 for SYRINGE 5ML HEPARIN 10 UNIT 306414 manufactured by Bd Medical (bd West) Medical Surgical.
| Report Number | 1911916-2019-01089 |
| MDR Report Key | 9191928 |
| Date Received | 2019-10-15 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-09-30 |
| 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 Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYRINGE 5ML HEPARIN 10 UNIT |
| Generic Name | HEPARIN, VASCULAR ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2019-10-15 |
| Catalog Number | 306414 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-15 |