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

Model Number 60726726

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

Bayer service performed a check of the stellant injector (serial number (b)(4)) and found it to perform to specification.The subject syringe kit was discarded at the site and was not available for investigation.The lot number was unable to be provided by the customer; therefore, testing of retained samples is not possible.

Event Description

The customer reported the following: a ct of the abdomen with contrast was being performed on a (b)(6) year old male with a history of cystic fibrosis while connected to a stellant injector (serial number (b)(4)).Following the contrast injection, the radiologist saw an undetermined amount of air in the cardiac cavity on the images.No unusual (technical) issues were reported during the procedure to explain the presence of air.The ct was completed and the patient was asymptomatic.The patient was kept for 24 hour observation.No problems were reported.

• Brand Name: STELLANT DUAL CT INJECTOR
• Type of Device: 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: linda mcdonald ; one bayer drive; indianola, PA 15051 ; 7249407412
• MDR Report Key: 7182499
• MDR Text Key: 96992482
• Report Number: 2520313-2018-00014
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60726726
• Device Catalogue Number: SCT D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 23 YR