MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-19 for STELLANT DUAL CT INJECTOR 81058881 SCT W/CERTEGRA manufactured by Bayer Medical Care, Inc..
[188648527]
Bayer service visited the customer site and performed a system checkout. The injector was found to perform to specifications. The disposables in the reported occurred were discarded and lot numbers are unavailable; therefore, the testing of retained samples is not possible. An offer for additional applications training was made and declined by the customer at this time.
Patient Sequence No: 1, Text Type: N, H10
[188648528]
The site reported the following: a (b)(6)-year-old female emergency room patient suffered an air injection while undergoing a pulmonary embolism ct exam with contrast media using a stellant injector. The amount of air is unknown; however, air was visualized on the images by the technologist who notified the radiologist. The patient was admitted to the hospital and a chest ct without contrast was performed 12 hours post occurrence, which showed the air had dissipated. No further intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520313-2020-00005 |
| MDR Report Key | 9726873 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-08 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2008-04-11 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | SUSAN SHERWIN |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal | 15051 |
| Manufacturer Phone | 7249408678 |
| Manufacturer G1 | BAYER MEDICAL CARE, INC. |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLANT DUAL CT INJECTOR |
| Generic Name | CT INJECTION SYSTEM |
| Product Code | DXT |
| Date Received | 2020-02-19 |
| Model Number | 81058881 |
| Catalog Number | SCT W/CERTEGRA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-02-19 |