MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for SURESTEP FOLEY TRAY SYSTEM LUBRI-SIL IC COMPLETE CARE A319516AM manufactured by C. R. Bard, Inc..
[184275782]
Foley catheter inserted, balloon inflated, eventually slid out due to balloon not remaining inflated. Inserted second foley catheter, balloon inflated, this catheter eventually backed out as well, balloon not inflated. Third catheter placed balloon inflated, successful, not backing out. The failed catheters were tested and showed defective balloons with obvious leaks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859691 |
| MDR Report Key | 9859691 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-06 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 LUBRI-SIL IC COMPLETE CARE |
| Generic Name | CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES |
| Product Code | MJC |
| Date Received | 2020-03-20 |
| Model Number | A319516AM |
| Catalog Number | A319516AM |
| Lot Number | NGDV3942 |
| Device Availability | N |
| 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 | 2020-03-20 |