MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-24 for CELSITE 4433750 manufactured by B.braun Medical Sas France.
| Report Number | 9612452-2020-00012 |
| MDR Report Key | 9872511 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2018-11-08 |
| Date Added to Maude | 2020-03-24 |
| 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 | MRS CATHERINE BOISMENU |
| Manufacturer Street | 30 AVENUE DES TEMPS MODERNES |
| Manufacturer City | CHASSENEUIL DU POITOU, 86360 |
| Manufacturer Country | FR |
| Manufacturer Postal | 86360 |
| Manufacturer G1 | B.BRAUN MEDICAL SAS FRANCE |
| Manufacturer Street | 30 AVENUE DES TEMPS MODERNES |
| Manufacturer City | CHASSENEUIL DU POITOU, 86360 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 86360 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSITE |
| Generic Name | ACCESS PORT SYSTEM |
| Product Code | LJT |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 4433750 |
| Lot Number | 36939309 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN MEDICAL SAS FRANCE |
| Manufacturer Address | 30 AVENUE DES TEMPS MODERNES CHASSENEUIL DU POITOU, 86360 FR 86360 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |