MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for MEDRAD? STELLANT STERILE DISPOSABLE SYRINGE SDS-CTP-SCS manufactured by Bayer Medical Care Inc..
[176787600]
After syringe tubing was connected to patient's piv, the syringe tubing became disconnected at the female port lure lock upon infusion of contrast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9641606 |
| MDR Report Key | 9641606 |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-19 |
| Report Date | 2020-01-10 |
| Date Reported to FDA | 2020-01-10 |
| Date Reported to Mfgr | 2020-01-29 |
| Date Added to Maude | 2020-01-29 |
| 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 | MEDRAD? STELLANT STERILE DISPOSABLE SYRINGE |
| Generic Name | INJECTOR AND SYRINGE, ANGIOGRAPHIC |
| Product Code | DXT |
| Date Received | 2020-01-29 |
| Model Number | SDS-CTP-SCS |
| Catalog Number | SDS-CTP-SCS |
| Lot Number | 8567906 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER MEDICAL CARE INC. |
| Manufacturer Address | 1 BAYER DRIVE INDIANOLA PA 15051 US 15051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |