MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-31 for UROLEX 01053 * manufactured by Carefusion.
[16322055]
Black debris was observed in bottom of the specimen container cup when sterile water was poured. This was noticed during a case set up. There was no patient impact. ==== reporter's responses ======reporter indicated they did not have similar problems before. The procedure was completed using a new product. Lot number was unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2048113 |
| MDR Report Key | 2048113 |
| Date Received | 2011-03-31 |
| Date of Report | 2011-03-31 |
| Date of Event | 2011-03-30 |
| Report Date | 2011-03-31 |
| Date Reported to FDA | 2011-03-31 |
| Date Added to Maude | 2011-04-11 |
| 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 |
| 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 | UROLEX |
| Generic Name | STERILE SPECIMEN CONTAINER |
| Product Code | LIO |
| Date Received | 2011-03-31 |
| Model Number | 01053 |
| Catalog Number | * |
| Lot Number | H362010530Z |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1850 DEMING WAY MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-31 |