MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for SILICONE FOLEY CATHETER manufactured by Cardinal Health 200, Llc.
[186305476]
Patient with the substitute 16 fr temp sensing foley placed last night, today he grabbed the tubing and the tubing came apart with very little effort, opening the system, allowing urine to spill out. There was a seal but it did not help in any way and fell off the tubing. This is a risk for infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9889756 |
| MDR Report Key | 9889756 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-25 |
| Report Date | 2020-02-27 |
| Date Reported to FDA | 2020-02-27 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| 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 | SILICONE FOLEY CATHETER |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2020-03-27 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |