MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for CUROS manufactured by 3m Company.
[136276417]
Green curos cap broke when being applied to leur lock. Small green circle broke from bottom of cap and stuck to leur lock. Had to use hemostats to take piece back off. Round green piece with antiseptic sponge remained intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8343051 |
| MDR Report Key | 8343051 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-08 |
| Date of Event | 2019-01-23 |
| Report Date | 2019-02-08 |
| Date Reported to FDA | 2019-02-08 |
| Date Reported to Mfgr | 2019-02-15 |
| Date Added to Maude | 2019-02-15 |
| 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 |
| 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 | CUROS |
| Generic Name | PAD, ALCOHOL, DEVICE DISINFECTANT |
| Product Code | LKB |
| Date Received | 2019-02-15 |
| Lot Number | 08210728 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |