MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-25 for DAVOL 0015850 manufactured by Bard/davol Inc..
[80315]
"urine" bag did not drain properly. The bag has a flutter value attached to the wrong end of the bag. Bile bag was improperly mfg. This is the third failure of this type in the past 9 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012005 |
| MDR Report Key | 117140 |
| Date Received | 1997-08-25 |
| Date of Report | 1997-08-25 |
| Date of Event | 1997-08-06 |
| Date Added to Maude | 1997-09-05 |
| 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 | DAVOL |
| Generic Name | BILE BAG |
| Product Code | EXF |
| Date Received | 1997-08-25 |
| Model Number | 0015850 |
| Catalog Number | 0015850 |
| Lot Number | 76EG2838 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 114885 |
| Manufacturer | BARD/DAVOL INC. |
| Manufacturer Address | P.O. BOX 8500 100 SOCKANOSSETT CROSSROAD CRANSTON RI 02920 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 1997-08-25 |