MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	85631829
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 9855994
• Report Number: 2520313-2020-00013
• Device Sequence Number: 2663919
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K192370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 85631829
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention