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

Model Number SDS-CTP-SPK

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2021

Event Type  malfunction  

Event Description

Upon loading for contrast on the medrad stellant injector, ct tech opened a new and sealed dual syringe kit and noticed two defects on the tubing of the male adaptor.Fda safety report id # (b)(4).

• Brand Name: MEDRAD STELLANT
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC; indianola PA 15051 0780
• MDR Report Key: 11273331
• MDR Text Key: 230708456
• Report Number: MW5099198
• Device Sequence Number: 1
• Product Code: DXT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SDS-CTP-SPK
• Device Lot Number: 8590469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1