MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-02 for TUBING C853-0126 manufactured by Coeur.
[96368721]
Syringe tubing spinning off while using power injector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074378 |
| MDR Report Key | 7159826 |
| Date Received | 2018-01-02 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-06-27 |
| Date Added to Maude | 2018-01-03 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | TUBING |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2018-01-02 |
| Returned To Mfg | 2017-07-06 |
| Model Number | C853-0126 |
| Lot Number | IAKXY-1704 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COEUR |
| Manufacturer Address | WASHINGTON NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-02 |