MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-25 for IRRIGATION SET 313003 manufactured by B. Braun Medical, Inc..
[112184465]
The drip chamber of the tubing for the continuous bladder irrigation was found to have a slow leak - the tubing was changed to new device without issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7633439 |
| MDR Report Key | 7633439 |
| Date Received | 2018-06-25 |
| Date of Report | 2018-06-20 |
| Date of Event | 2018-06-14 |
| Date Reported to Mfgr | 2018-06-25 |
| Date Added to Maude | 2018-06-25 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-06-25 |
| Model Number | 313003 |
| Catalog Number | 313003 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Manufacturer Address | 901 MARCON BLVD ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-25 |