MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-26 for BARDEX FOLEY * 165812 manufactured by C. R. Bard Inc..
[3912088]
A 12 fr foley inserted without difficulty at beginning of surgical case. At the end of the case, rn removed all of the fluid out of the balloon and began to pull the foley out. When rn got to the tip of the penis the foley would not come any further. Urology was paged. Urology began to tug on foley and removed it with force. The catheter came out intact. There was a lip on the end of the foley right below the balloon. Patient did not require further medical care as a result; however, pt was under the affects of anesthesia at the time the catheter was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3420131 |
| MDR Report Key | 3420131 |
| Date Received | 2013-09-26 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-09-17 |
| Report Date | 2013-09-26 |
| Date Reported to FDA | 2013-09-26 |
| Date Reported to Mfgr | 2013-10-21 |
| Date Added to Maude | 2013-10-21 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARDEX FOLEY |
| Generic Name | KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER |
| Product Code | FCN |
| Date Received | 2013-09-26 |
| Model Number | * |
| Catalog Number | 165812 |
| Lot Number | NGXF0316 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD INC. |
| Manufacturer Address | * SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-26 |