MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-06 for FOLEY CATHETER * UNKNOWN manufactured by C.r. Bard Inc..
[16545865]
At 9 am patient assessment, it was noted that there was an indention along the patient's scrotum where catheter tubing was secured. Moved catheter to other leg with slack in tubing. At 11 am noted no urine output since moving tube and significant increase in penile swelling. Resident and fellow to beside to assess. Per fellow, rn deflated balloon on foley, large amount of urine output noted. Upon re-inflating balloon, bleeding from insertion site at penis noted. Balloon immediately deflated. Urology to bedside to assess. Urology recommended advancing catheter then re inflating balloon with 3ml. Two rn's advanced catheter as sterilly as possible. When attempting to re inflate balloon, balloon was noted to be defective. Resident attempted to replace foley without success. After multiple attempts 6fr foley was placed with no urine output. Md then deflated balloon, large amount of blood came out of foley. Urologist then removed the 6 fr foley and successfully had the 6 fr foley replaced. Patient's urine has cleared and no additional reports of problems with foley's.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3904488 |
| MDR Report Key | 3904488 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-06-06 |
| Date of Event | 2014-04-30 |
| Report Date | 2014-06-06 |
| Date Reported to FDA | 2014-06-06 |
| Date Reported to Mfgr | 2014-07-01 |
| Date Added to Maude | 2014-07-01 |
| 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 |
| 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 | FOLEY CATHETER |
| Generic Name | KIT, CATHETER, URINARY |
| Product Code | FCN |
| Date Received | 2014-06-06 |
| Model Number | * |
| Catalog Number | UNKNOWN |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD INC. |
| Manufacturer Address | 730 CENTRAL AVE. MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-06 |