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

Model Number	60729369
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis received and examined the returned product.Visual examination confirmed the presence of a yellow particulate from an unknown source inside the barrel of the syringe.The likely cause of the reported problem was determined to be the introduction of an unidentified particulate during component manufacturing.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 customer reported the following: after opening the stellant ct disposable kit and upon inspection, they observed yellow debris within the syringe barrel.The customer elected not to use the syringe kit.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, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 7103725
• Report Number: 2520313-2017-00076
• Device Sequence Number: 1069447
• Product Code: DXT
• UDI-Device Identifier: 00616258005256
• UDI-Public: (01)00616258005256(11)17102(17)211021(10)8535011
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/11/2017

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: 10/21/2021
• Device Model Number: 60729369
• Device Catalogue Number: SDS-CTP-SCS
• Device Lot Number: 8535011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1