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

Model Number	85937286
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer medical care inc.Was informed of an alleged air injection while a patient was connected to a medrad® stellant ct injection system (sn (b)(6)).Although the patient was asymptomatic throughout the examination, the patient was subsequently hospitalized for observation and has since recovered.
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system (serial number (b)(6)) has been scheduled.The disposable kit in use during the event is unavailable and disposable information is unknown.The site continues to use the medrad® stellant ct injection system after the reported event with no further issues reported.This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system (serial number (b)(6)) was completed on november 21, 2023 which confirmed the injector was performing within bayer specifications.The disposable kit in use during the event is unavailable and disposable information is unknown.An offer of additional clinical applications training has been made to the customer and was declined.The site continues to use the medrad® stellant ct injection system after the reported event with no further issues reported.The medrad® stellant ct injection system operation manual cautions the user as follows: warning: air embolization can cause death or serious injury to the patient.Do not connect a patient to the injector until all trapped air has been cleared from the syringe and fluid path.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Event or Problem Description
Bayer medical care inc.Was informed of an alleged air injection while a patient was connected to a medrad® stellant ct injection system (sn (b)(6)).Although the patient was asymptomatic throughout the examination, the patient was subsequently hospitalized for observation and has since recovered.
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system (serial number (b)(6)) has been scheduled and we are awaiting the results.The disposable kit in use during the event is unavailable and disposable information is unknown.The site continues to use the medrad® stellant ct injection system after the reported event with no further issues reported.This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Additional Manufacturer Narrative
Udi related data quality updates only.Correction: for udi data discrepancy/mismatch on previously submitted mdr and to ensure the device identification data is in alignment with gudid.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 18041335
• Report Number: 2520313-2023-00028
• Device Sequence Number: 7499915
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860(11)220203
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 85937286
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 11/21/2023; Not provided
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/16/2023; 12/12/2023; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Male