MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-09 for SURECAN SAFETY II 4447005-02 manufactured by B. Braun Medical France.
| Report Number | 9612452-2019-00091 |
| MDR Report Key | 8878639 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-08-09 |
| Date of Report | 2019-08-09 |
| Date Mfgr Received | 2019-07-18 |
| Date Added to Maude | 2019-08-09 |
| 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 | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| Manufacturer G1 | B. BRAUN MEDICAL FRANCE |
| Manufacturer Street | 30 AVENUE DES TEMPS MODERNES |
| Manufacturer City | 86360 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 86360 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURECAN SAFETY II |
| Generic Name | NON-CORING (HUBER) NEEDLE |
| Product Code | PTI |
| Date Received | 2019-08-09 |
| Model Number | 4447005-02 |
| Catalog Number | 4447005-02 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-08-09 |