MAUDE Adverse Event Report: BAYER MEDICAL CARE STELLANT CT SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT

Model Number	60728737
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis received and examined the returned product.Visual examination of the returned product confirmed the presence of particulate inside the barrel of the syringe.Examination of the particle found in the syringe appears to be a plastic/vinyl type material.The particulate measures approximately 2.25 cm in length and 0.25 cm in width.Our investigation determined that the particulate noted in the syringe was introduced during the manufacturing process.The syringe kit instructions for use instructs the user to "visually inspect contents and package before each use".This visual inspection is to ensure particulates are noticed and mitigated, which is what occurred in this reported instance.
Event or Problem Description
The following information was obtained from the customer: the customer reported observing a white paper like particulate inside the ct syringe barrel upon opening the syringe kit before use on a patient.No injury or adverse event was reported.

• Brand Name: STELLANT CT SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE; 1 bayer drive; indianola PA 15051
• MDR Report Key: 6479720
• Report Number: 2520313-2017-00024
• Device Sequence Number: 1290008
• Product Code: DXT
• UDI-Device Identifier: 10616258005185
• UDI-Public: (01)10616258005185(11)161016(17)201016(10)8522316
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2017

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: 10/16/2020
• Device Model Number: 60728737
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8522316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1