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 2020-03-19 for STELLANT DUAL CT INJECTOR 85631829 SCT FLEX manufactured by Bayer Medical Care, Inc..
[186377317]
Bayer service visited the customer site and replaced the syringe housing, size sensor, and id board, which restored the system to normal operation. Bayer service noted that the customer had damaged the syringe size sensor when attempting to incorrectly rectify the situation. The broken syringe was discarded by the customer and a lot number was unable to be provided; therefore, testing of a retained sample is not able to be performed. Bayer product analysis reviewed a photograph of the injector housing taken by bayer service following the incident; however, the photograph was inconclusive. The operation manual contains the following excerpts from the electro-mechanical hazard and inspecting the injection system sections. Do not remove any covers or disassemble the injector. Contact bayer or a local dealer for service or repairs.
Patient Sequence No: 1, Text Type: N, H10
[186377318]
The following information was reported to bayer: a syringe broke while a technologist was attempting to remove the syringe from the stellant flex injector system. Following the occurrence, a portion of the syringe remained engaged within the injector system. The technologist used a pair of scissors to try and retrieve the broken portion of the syringe and in doing so, punctured the palm of his hand with the scissors. A safety report was filed at the customer site and the technologist was evaluated at occupational health the morning after the incident occurred. The technologist was given a tetanus shot for prevention and instructed to follow up with occupational health as needed. The technologist has been reported to recover and no further treatment has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520313-2020-00013 |
| MDR Report Key | 9855994 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2020-01-20 |
| Date Added to Maude | 2020-03-19 |
| 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 | 2020-03-19 |
| Model Number | 85631829 |
| Catalog Number | SCT FLEX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-19 |