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

Model Number	60728753
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information, we are unable to determine the root cause of the unknown particle 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 saw a foreign body on one of the filling spikes.The customer elected not to use the spike.No injury or adverse event was reported.
Additional Manufacturer Narrative
Bayer radiology product analysis reviewed the photographs as well as the complaint details that were provided by the customer.Visual examination confirmed the presence of a black particulate on the spike surface.However, as the subject product was retained by the customer and not made available for our evaluation, dimensional examination and particle characterization could not be performed or determined.This information does not constitute an admission that the device, the company or its employees caused or contributed to this reportable event.

• 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: 6673135
• Report Number: 2520313-2017-00041
• Device Sequence Number: 72282
• Product Code: DXT
• UDI-Device Identifier: 00616258007939
• UDI-Public: (01)00616258007939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 07/11/2017

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: 10/28/2020
• Device Model Number: 60728753
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8526033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1