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

Model Number	60728699
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information, we are unable to determine the root cause of the unknown particles at this time; however, the product is scheduled to return to bayer for a full evaluation.Once the evaluation is completed, a follow-up report will be submitted.
Event or Problem Description
The customer reported the following: after opening the stellant ct disposable kit and upon inspection, they noticed the presence of fine white particles around the syringe as well as the quick fill tube (qft).The customer elected not to use the syringe kit.No injury or adverse event was reported.Note: reference the following report numbers for related reports: 2520313-2017-00003.2520313-2017-00005.

• Brand Name: STELLANT CT SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 6245457
• Report Number: 2520313-2017-10004
• Device Sequence Number: 967647
• Product Code: DXT
• UDI-Device Identifier: 10616258005178
• UDI-Public: (01)10616258005178(11)161028(17)201028(10)8522845
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/12/2017

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: 10/28/2020
• Device Model Number: 60728699
• Device Catalogue Number: SDS-CTP-QFT
• Device Lot Number: 8522845
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1