MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-02-12 for BD? SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE? SAFETY NEEDLE 305945 manufactured by Bd Medical - Diabetes Care.
| Report Number | 1920898-2020-00121 |
| MDR Report Key | 9700080 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-06-17 |
| Date Added to Maude | 2020-02-12 |
| 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 | 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 - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD? SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE? SAFETY NEEDLE |
| Generic Name | PISTON SYRINGE |
| Product Code | MEG |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 305945 |
| Catalog Number | 305945 |
| Lot Number | 9168602 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |