MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. SPECTRIS SOLARIS SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT

Model Number	60728567
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis received and examined the returned product.Visual examination confirmed the presence of a particulate in the lpct.The particulate was identified 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 mr disposable kit and upon inspection, they saw a foreign body within the lpct (low pressure connector tubing).The customer elected not to use the tubing.No injury or adverse event was reported.

• Brand Name: SPECTRIS SOLARIS SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 6928180
• Report Number: 2520313-2017-00063
• Device Sequence Number: 1223772
• Product Code: DXT
• UDI-Device Identifier: 00616258005423
• UDI-Public: (01)00616258005423(11)170413(17)220413(10)8404810
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K012950
• 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): 10/09/2017

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: 04/13/2022
• Device Model Number: 60728567
• Device Catalogue Number: SSQK 65/115VS
• Device Lot Number: 8404810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1