MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for BARD FOLEY CATHETER TRAY manufactured by C.r.bard, Inc.
[138274154]
Foley was removed with force and tip inspected. The balloon rolled in itself to create a donut around the tip. The balloon was re-inflated to ensure it had not torn while inside the patient. The balloon was verified to be intact. The position of the balloon when it was in the patient it had rolled up to cause a donut which created a larger and larger diameter as it came to the end of the urethra. This potential is a product failure and causing unnecessary pain to patient. Dates of use: 5 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084748 |
| MDR Report Key | 8403437 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-03-05 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | BARD FOLEY CATHETER TRAY |
| Generic Name | CATHETER CARE TRAY |
| Product Code | OHR |
| Date Received | 2019-03-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R.BARD, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-07 |