MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-24 for BILE BAG REGULAR * 0015850 manufactured by Davol Inc..
[20205092]
The bile bag was improperly mfg. The drainage end of the bag with flutter valve was connected to the bottom outlet which wouldn't allow complete drainage. Normally the valve is at the top of the bag with connector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010608 |
| MDR Report Key | 64594 |
| Date Received | 1997-01-24 |
| Date of Report | 1997-01-09 |
| Date of Event | 1996-12-01 |
| Date Added to Maude | 1997-01-28 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BILE BAG REGULAR |
| Generic Name | BILE DRAINAGE BAG |
| Product Code | EXF |
| Date Received | 1997-01-24 |
| Model Number | * |
| Catalog Number | 0015850 |
| Lot Number | 76KF2130 |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 64717 |
| Manufacturer | DAVOL INC. |
| Manufacturer Address | 100 SOCKANOSSETT CROSS RD P.O. BOX 8500 CRANSTON RI 02920 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-24 |