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

Model Number	85937286
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer service performed a system service check of the stellant ct injector (sn (b)(4)) on april 22, 2022, and determined the injector was operating to specification.The customer discarded the suspect disposables at the time of the incident; however, they were able to provide a lot number for the stellant ct disposable kit.The testing of a retained sample is pending.Once the evaluation is completed, a follow-up report will be submitted.Additional applications training was offered; however, the customer declined.
Event or Problem Description
The customer reported the following: an 8-year old male with a history of cancer was undergoing a ct scan of the chest to evaluate for metastases.The patient had a hickman dual lumen port implanted in the upper chest area to which the stellant ct injector system (sn (b)(4)) was connected.After successful completion of the procedure, the patient was evaluated and found to have a large swollen area over the port site.The customer reported that one of the lumens of the port was damaged during the injection after which the patient required surgical removal and replacement of the port.The current status of the patient is unknown.
Additional Manufacturer Narrative
Bayer product analysis tested a retained sample from stellant ct disposable sds-ctp-spk kit, lot number 8612062.No visual or functional defects were identified.Functional testing concluded that the retained disposables performed to specification with no problems observed.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.

• 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
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; 1 bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 14433944
• Report Number: 2520313-2022-00021
• Device Sequence Number: 14753144
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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-CTP-SPK - LOT NUMBER. 8612062
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Sex: Male