MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD STELLANT STERILE DISPOSABLE SYRINGE; INJECTOR SYRINGE

Catalog Number	SDS-CTP-SCS
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
T-connector (from sterile disposable syringe kit) fell off in technologist's hand when attempting to connect tubing to power injector.

• Brand Name: MEDRAD STELLANT STERILE DISPOSABLE SYRINGE
• Common Device Name: INJECTOR SYRINGE
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; indianola PA 15051
• MDR Report Key: 7482460
• Report Number: MW5076993
• Device Sequence Number: 10803004
• Product Code: DXT
• UDI-Device Identifier: 00616258005256
• UDI-Public: 00616258005256
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: 03/11/2022
• Device Catalogue Number: SDS-CTP-SCS
• Device Lot Number: 8542622
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other