MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-18 for DRAINAGE BAG UNK 72110511 manufactured by B Braun Medical, Inc.
[21704757]
Drainage bag ruptured when bag gets filled to a certain level. Drainage runs all over the floor and drain amount accuracy is not known any longer due to rupture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 812212 |
| MDR Report Key | 812212 |
| Date Received | 2007-01-18 |
| Date of Report | 2007-01-12 |
| Date of Event | 2006-12-21 |
| Report Date | 2007-01-12 |
| Date Reported to FDA | 2007-01-18 |
| Date Added to Maude | 2007-02-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAINAGE BAG |
| Generic Name | BAG, DRAINAGE |
| Product Code | FIF |
| Date Received | 2007-01-18 |
| Returned To Mfg | 2007-01-02 |
| Model Number | UNK |
| Catalog Number | 72110511 |
| Lot Number | 061124 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 799695 |
| Manufacturer | B BRAUN MEDICAL, INC |
| Manufacturer Address | MANUFACTURING DIVISION 901 MARCON BOULEVARD ALLENTOWN PA 18109 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-18 |