MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for SURESTEP? FOLEY TRAY SYSTEM BARDEX? IC COMPLETE CARE? A303316A manufactured by C. R. Bard, Inc..
[183124167]
Foley catheter was inserted and bag noted to be leaking. The hard plastic portion's valve was leaking. The connection was tight.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9824110 |
| MDR Report Key | 9824110 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-14 |
| Report Date | 2020-01-23 |
| Date Reported to FDA | 2020-01-23 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| 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 | SURESTEP? FOLEY TRAY SYSTEM BARDEX? IC COMPLETE CARE? |
| Generic Name | CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES |
| Product Code | MJC |
| Date Received | 2020-03-12 |
| Model Number | A303316A |
| Catalog Number | A303316A |
| Lot Number | NGDW2416 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |