MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-23 for BARD 154002 manufactured by C. R. Bard, Inc..
[9550]
Numerous patients developed "leaking" at atheri foley catheter devices. Contact was made with bard urological division. Foley catheter leaking at connection site. Leaking under plastic lip (also noted hairline crack in tubing).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 11699 |
| MDR Report Key | 11699 |
| Date Received | 1994-02-23 |
| Date of Report | 1993-12-13 |
| Date of Event | 1993-12-08 |
| Date Added to Maude | 1994-02-24 |
| 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 | BARD |
| Generic Name | BARD URINARY DRAINAGE BAG SYSTEM |
| Product Code | EYZ |
| Date Received | 1994-02-23 |
| Model Number | 154002 |
| Lot Number | VARIOUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11699 |
| Manufacturer | C. R. BARD, INC. |
| Manufacturer Address | COVINGTON GA 30209 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-02-23 |