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

Model Number	60728737
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer quality assurance product analysis received and examined the returned syringe, lot #8538307.Visual examination of the returned product confirmed the presence of a particle in the syringe barrel.The particle is white in color and appears to be pliable plastic.The particle was introduced into the syringe prior to filling, likely during component manufacturing or assembly.A 12 month review of complaint history determined the frequency to be (b)(4) complaints per million (cpm) for similar defects.
Event or Problem Description
The site reported the following: a stellant sds-ctp-spk syringe was filled with contrast media using a spike into the contrast media vial and a white, plastic-like particle was noted to be floating in the contrast inside the syringe.The kit was removed from the area and was not used for a patient.

• Brand Name: STELLANT CT SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• MDR Report Key: 7156864
• Report Number: 2520313-2018-00001
• Device Sequence Number: 16161405
• Product Code: DXT
• UDI-Device Identifier: 00616258005188
• UDI-Public: (01)00616258005188(11)171002(17)211002
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: 60728737
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8538307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1