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	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis received and examined the returned tube set.Visual examination identified the particulate as degraded resin.Degraded resin can collect on the extrusion tooling and be introduced during the manufacturing process.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 the customer observed a black particulate inside the tubing.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: 7230619
• Report Number: 2520313-2018-00018
• Device Sequence Number: 1994783
• Product Code: DXT
• UDI-Device Identifier: 00616258005218
• UDI-Public: (01)00616258005218(11)171208(17)211208(10)8538707
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/29/2018

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: 12/08/2021
• Device Model Number: 60728818
• Device Catalogue Number: SSS-CTP-SPK
• Device Lot Number: 8538707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1