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	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system (serial number(b)(6) was performed (b)(6) 2024 which confirmed that the injector was operating within bayer specifications.The medrad® stellant sterile disposable syringe kit (sds-trf-cv), lot number 8636608, in use during the procedure is being returned for a full evaluation.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.
Event or Problem Description
Bayer medical care inc.Was informed that a 74-year-old female suffered an alleged air injection while connected to a medrad® stellant ct injection system (sn (b)(6).The customer reported that a physician observed approximately 10 ml of free air on the displayed images.After an undisclosed period, the patient was sent for a follow-up ct scan.The current health status of the patient is unknown.
Event or Problem Description
Bayer medical care inc.Was informed that a 74-year-old female suffered an alleged air injection while connected to a medrad® stellant ct injection system (sn (b)(6)).The customer reported that a physician observed approximately 10 ml of free air on the displayed images.After an undisclosed period, the patient was sent for a follow-up ct scan.The current health status of the patient is unknown.
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system (serial number (b)(6) was performed (b)(6) 2024 which confirmed that the injector was operating within bayer specifications.The offer of additional applications training was accepted and provided by the bayer clinical performance team.Bayer product analysis tested the medrad® stellant sterile disposable syringe kit (sds-trf-cv), lot number 8636608, in use during the procedure and concluded that it performed to specification with no problems observed.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.
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: 18779380
• Report Number: 2520313-2024-00003
• Device Sequence Number: 12857789
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860(11)220328
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 09/25/2024

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: 02/12/2024
• Supplement Date Received by Manufacturer: 02/12/2024; Not provided
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/11/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SDS-TRF-CV - LOT: 8636608.; SDS-TRF-CV - LOT: 8636608.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female