MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for CUROS manufactured by 3m Company.
[173484502]
Patient with picc line had green, disinfecting end cap over picc line needleless connector, per standard. When rn attempted to removed/unscrew the green, disinfecting end cap, it broke into two pieces and part of the green, disinfecting end cap was stuck/remained on the picc line needleless connector. Rn was unable to get the piece of the green, disinfecting end cap off and the picc line needleless connector had to be changed by the vascular access team rn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9543678 |
| MDR Report Key | 9543678 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-11-27 |
| Report Date | 2019-12-03 |
| Date Reported to FDA | 2019-12-03 |
| Date Reported to Mfgr | 2020-01-03 |
| Date Added to Maude | 2020-01-03 |
| 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 | CUROS |
| Generic Name | PAD, ALCOHOL, DEVICE DISINFECTANT |
| Product Code | LKB |
| Date Received | 2020-01-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2020-01-03 |