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

Model Number	60728818
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis reviewed a photo provided of the suspect syringe.Particulate was visualized within the photo.The product is unable to return for evaluation as it was discarded by the customer.Based on the limited information, we are unable to determine the root cause of the unknown particle.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.This information does not constitute an admission that the device, the company or its employees caused or contributed to this reportable event.
Event or Problem Description
The site reported the following: a radiologic technologist removed a syringe from the syringe kit packaging, spiked a bottle of contrast media and began to fill the syringe with contrast media.About 2/3 of the contrast was into the syringe when he noted 1 or 2 black flecks floating in the contrast.He stopped filling the syringe and took a photo of the black fleck.He then removed the syringe and discarded it.The syringe was never 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: 6706430
• Report Number: 2520313-2017-00047
• Device Sequence Number: 16544591
• Product Code: DXT
• UDI-Device Identifier: 00616258005218
• UDI-Public: (01)00616258005218
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/12/2017

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: 03/29/2021
• Device Model Number: 60728818
• Device Catalogue Number: SSS-CTP-SPK
• Device Lot Number: 8528965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1