MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for BARDEX IC FOLEY CATHETER JC9058 manufactured by C. R. Bard, Inc..
[184279332]
Order to disconnect foley catheter given. Balloon was deflated on device and 15 cc return. Attempted to pull catheter out and it become lodged and would not move. Urology pa notified. Balloon port was clipped by pa but unable to remove foley. Pa could feel balloon in patient's prostate, therefore possible defect in balloon. Urology continuing to work to remove foley. Foley was removed by urology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859584 |
| MDR Report Key | 9859584 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-04 |
| Report Date | 2020-02-13 |
| Date Reported to FDA | 2020-02-13 |
| 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 |
| 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 | BARDEX IC FOLEY CATHETER |
| Generic Name | CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES |
| Product Code | MJC |
| Date Received | 2020-03-20 |
| Catalog Number | JC9058 |
| Lot Number | 0167L24 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BOULEVARD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |