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 2020-02-12 for STELLANT DUAL CT INJECTOR 58746456 SCT D manufactured by Bayer Medical Care Inc..
[188648061]
A system service check of the stellant ct injector, serial number (b)(4), was completed on january 29, 2020 which confirmed that the injector was operating within bayer specifications. There was no evidence of equipment malfunction. The stellant disposable set that was in use during the procedure was discarded by the site; however, the lot number that was in use during the time of the incident was provided. Bayer product analysis tested a retained sample from sds-ctp-qft, lot number 8572269. No visual or functional defects were identified. Functional testing concluded that the retained disposables performed to specification with no problems observed. Additional applications training was offered; however, the site declined. The site continues to use the stellant ct injection system after the reported event with no further issues reported.
Patient Sequence No: 1, Text Type: N, H10
[188648062]
Bayer medical care was notified of an extravasation that occurred during an enhanced ct scan of the abdomen and pelvis while a patient was connected to a stellant ct injection system. The customer reported that an undisclosed amount of contrast extravasated in the patient's right antecubital space during the injection. Approximately 3 hours after the exam was completed, the patient called the facility to report that their right arm was swollen and painful. The facility staff referred the patient to their physician and at the time of the call recommended applying an icepack and elevating the affected extremity. The patient was re-evaluated the following day at their scheduled urology follow-up appointment and, while on site, the physician examined the extremity and noted the presence of normal pulses and mild induration with no evidence of tissue damage. No further medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520313-2020-00004 |
| MDR Report Key | 9701368 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2003-09-22 |
| Date Added to Maude | 2020-02-12 |
| 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 | DIANE ECKERT |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal | 15051 |
| Manufacturer Phone | 7249408677 |
| 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 | 2020-02-12 |
| Model Number | 58746456 |
| Catalog Number | SCT D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2020-02-12 |