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

Model Number	FLEXD-150-SPK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Upon loading for contrast on the medrad stellant injector, ct tech opened a new and sealed dual syringe kit to load contrast and saline.Syringes were placed on injector.Tech had difficulty trying to attach enclosed spike to tip of syringe.Upon closer inspection, tech noticed a small plastic piece in the male luer lock well of the threaded section of the tip.The syringe was removed from injector, plastic piece was removed from the well and not used.No patient harm.Fda safety report id # (b)(4).

• Brand Name: MEDRAD STELLANT FLEX
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC; indianola PA 15051 0780
• MDR Report Key: 12057962
• Report Number: MW5102093
• Device Sequence Number: 3832449
• Product Code: DXT
• UDI-Device Identifier: 00616258022901
• UDI-Public: (01)00616258022901
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: 03/17/2025
• Device Model Number: FLEXD-150-SPK
• Device Catalogue Number: FLEXD-150-QFT
• Device Lot Number: 8597304
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1