MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD ANGIOGRAPHIC/CT INJECTOR

Model Number	86410095
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® mark 7 arterion injection system (serial number (b)(6)) was completed on september 20, 2023 by bayer service.A review of the system flight recorder log files confirmed that there were zero entries.This indicates that no error messages were recorded.Bayer service concluded that the system was operating to specification.Multiple documented attempts have been made to gain specific information related to the reported event; however, these attempts have been unsuccessful.In the event that additional information is obtained, 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
The customer reported that a patient death and potential but unconfirmed air injection occurred while a medrad® mark 7 arterion injection system (serial number (b)(6)) was in use.No further information was provided.
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: MEDRAD ANGIOGRAPHIC/CT INJECTOR
• Common Device Name: ANGIOGRAPHIC/CT INJECTOR
• 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: 17916338
• Report Number: 2520313-2023-00025
• Device Sequence Number: 14198817
• Product Code: DXT
• UDI-Device Identifier: 00616258021362
• UDI-Public: (01)00616258021362(11)220221
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K113133
• 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: Biomedical Engineer
• Type of Report: Initial,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: 86410095
• Device Catalogue Number: ART 700 TABL
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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: Death
• Patient Sex: Unknown