MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for TRIOX 7110-EP8-H 50328-07 manufactured by Icu Medical Inc..
[140601499]
Anesthesia provider was inserting a pulmonary artery catheter when it became difficult to retract. The catheter could be advanced, just not retracted. The inability to place the catheter in the desired anatomical position, resulted in the anesthesia provider attempting to withdraw the catheter. The catheter could not be discontinued and removed without removing the cordis as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8472766 |
| MDR Report Key | 8472766 |
| Date Received | 2019-04-02 |
| Date of Report | 2019-02-19 |
| Date of Event | 2019-02-18 |
| Report Date | 2019-02-19 |
| Date Reported to FDA | 2019-02-19 |
| Date Reported to Mfgr | 2019-04-02 |
| Date Added to Maude | 2019-04-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | TRIOX |
| Generic Name | CATHETER, OXIMETER, FIBER-OPTIC |
| Product Code | DQE |
| Date Received | 2019-04-02 |
| Model Number | 7110-EP8-H |
| Catalog Number | 50328-07 |
| Lot Number | 3914350 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL INC. |
| Manufacturer Address | 951 CALLE AMANECER SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-02 |