MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-24 for BRAUN EXTENSION TUBING NOT AVAILABLE manufactured by Braun.
[53555766]
Braun extension needed to be replaced on several pts. The tubing often did not allow fluids to run free flow when needed. It often will not allow piggyback fluids to run. The tubing had to be changed on several pts. The iv pump was first replaced to r/o pump failure. No pt data available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064389 |
| MDR Report Key | 5910159 |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-11 |
| Date Added to Maude | 2016-08-29 |
| 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 | BRAUN EXTENSION TUBING |
| Generic Name | EXTENSION TUBING |
| Product Code | OJA |
| Date Received | 2016-08-24 |
| Model Number | NOT AVAILABLE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAUN |
| Manufacturer Address | BETHLEHEM PA 18018 US 18018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-24 |