MAUDE Adverse Event Report: BAYER MEDICAL CARE INC BAYER MEDRAD STELLANT FLEX CT SYRINGE WITH TUBING; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	FLEXD-150-SPK
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At (b)(6) hospital, on (b)(6) 2023 in ct, contrast sprayed out of the syringe connection tubing during a patient injection.The contrast came out of a fixed manufacturer connection point, not from a connection point that the staff connects manually.The is potentially dangerous because it could introduce air into the patient.It could also spray contrast into the eyes of a patient.Syringe ref # flexd-150-spk, lot # 8624657, exp date 2026-09-30.

• Brand Name: BAYER MEDRAD STELLANT FLEX CT SYRINGE WITH TUBING
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC
• MDR Report Key: 17011216
• Report Number: MW5117928
• Device Sequence Number: 6343840
• Product Code: DXT
• UDI-Device Identifier: 00616258022833
• UDI-Public: (01)00616258022833
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: FLEXD-150-SPK
• Device Catalogue Number: FLEXD-150-SPK
• Device Lot Number: 8624657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian