MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-24 for SURECAN SAFETY II 4447012-02 manufactured by B. Braun Medical France.
| Report Number | 2532083-2019-00002 |
| MDR Report Key | 8821591 |
| Date Received | 2019-07-24 |
| Date of Report | 2019-07-24 |
| Date Facility Aware | 2019-06-26 |
| Report Date | 2019-07-24 |
| Date Reported to FDA | 2019-07-24 |
| Date Reported to Mfgr | 2019-07-24 |
| Date Added to Maude | 2019-07-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURECAN SAFETY II |
| Generic Name | SET, ADMINISTRATION, INTRA |
| Product Code | PTI |
| Date Received | 2019-07-24 |
| Model Number | 4447012-02 |
| Catalog Number | 4447012-02 |
| Lot Number | 17L24G8661 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL FRANCE |
| Manufacturer Address | 30 AVENUE DES TEMPS MODERNES 86360 FR 86360 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-24 |