MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-30 for DARBY PRIVATE LABEL NEEDLE 30GA SHORT 03N1301 manufactured by Sofic Sas.
| Report Number | 0001721729-2019-00003 |
| MDR Report Key | 9255028 |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-30 |
| Date Facility Aware | 2019-02-12 |
| Report Date | 2019-10-01 |
| Date Reported to Mfgr | 2019-10-01 |
| Date Added to Maude | 2019-10-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DARBY PRIVATE LABEL NEEDLE 30GA SHORT |
| Generic Name | DARBY PRIVATE LABEL NEEDLE |
| Product Code | DZM |
| Date Received | 2019-10-30 |
| Catalog Number | 03N1301 |
| Lot Number | F08243AA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOFIC SAS |
| Manufacturer Address | 3, RUE JEAN-JACQUES ROUSSEAU AUSSILLON MAZAMET CEDEX, 81207 FR 81207 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-10-30 |