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

Model Number	60728605
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
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 solaris mr disposable kit and upon inspection, they saw a foreign body within the low pressure connector tubing (lpct).The customer elected not to use the disposable kit.No injury or adverse event was reported.
Additional Manufacturer Narrative
Bayer product analysis received and examined one returned low pressure connector tubing (lpct).Visual examination confirmed the presence of a particle within the tube set.The particle was identified as degraded resin from the tubing extrusion process and was partially connected to the inside wall of the tubing.As the particle was partially embedded into the tubing wall, there is a potential that it could fragment while under pressures typically generated during an injection.Therefore, the potential of injection into a patient exists.Our investigation determined that the particle noted in the lpct was introduced during the manufacturing process and was not detected upon receipt of the product from the supplier.A 12 month review of complaint history determined the complaint rate to be 0.57 complaints per million (cpm).

• 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: 7238038
• Report Number: 2520313-2018-00020
• Device Sequence Number: 1222666
• Product Code: DXT
• UDI-Device Identifier: 00616258005461
• UDI-Public: (01)00616258005461
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 02/09/2018

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: 06/01/2022
• Device Model Number: 60728605
• Device Catalogue Number: SSQK 115
• Device Lot Number: 8405966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1