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

Model Number	60728699
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2017
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 within the low pressure connector tubing (lpct).The customer elected not to use the tubing.No injury or adverse event was reported.
Additional Manufacturer Narrative
Product analysis received and examined the returned product.Visual examination identified the particulate as degraded resin that is partially embedded in the tubing wall and extends into the fluid pathway.The cause of the reported problem is degraded compound (resin) that collected on the extrusion tooling and became partially embedded in the tubing as it was formed during manufacturing.A 12 month review of complaint history determined the frequency to be 0.59 complaints per million (cpm) for similar defects.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: 6803395
• Report Number: 2520313-2017-00052
• Device Sequence Number: 18869356
• Product Code: DXT
• UDI-Device Identifier: 00616258005171
• UDI-Public: (01)00616258005171(11)170710(17)210710(10)8535328
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 09/26/2017

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: 07/10/2021
• Device Model Number: 60728699
• Device Catalogue Number: SDS-CTP-QFT
• Device Lot Number: 8535328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1