MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-06 for TEVADAPTOR SYRINGE ADAPTOR M7286P15 412118 manufactured by B.braun.
[46874547]
Trabectedin tubing found to be deattached from white chemo adapter, small blood puddle found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062733 |
| MDR Report Key | 5707048 |
| Date Received | 2016-06-06 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-05-18 |
| Date Added to Maude | 2016-06-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 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 | 0 |
| Brand Name | TEVADAPTOR SYRINGE ADAPTOR |
| Generic Name | ADAPTOR |
| Product Code | FJP |
| Date Received | 2016-06-06 |
| Model Number | M7286P15 |
| Catalog Number | 412118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B.BRAUN |
| Manufacturer Address | BETHLEHEM PA 18018 US 18018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-06 |