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

Model Number	60728591
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information, we are unable to determine the root cause of the unknown foreign material 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: upon opening the solaris mr disposble kit and upon inspection, the noticed foreign material within the syringe barrel.The customer elected not to use the syringe.No injury or adverse event was reported.
Additional Manufacturer Narrative
Bayer radiology product analysis received and examined the returned contrast syringe and determined that the small black particulates were embedded and fully encased within the syringe material.Dimensional examination of the three embedded particles were 0.15, 0.10, and 0.05 square millimeters respectively.As the particles were completely embedded into the syringe material, the potential of injection into a patient does not exist.Our investigation determined that the particulates noted in the syringe were introduced during the manufacturing process and were not detected upon receipt of the product from the supplier.

• Brand Name: SPECTRIS SOLARIS SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola, pa
• MDR Report Key: 10226346
• Report Number: 2520313-2020-00025
• Device Sequence Number: 11289685
• Product Code: DXT
• UDI-Device Identifier: 00616258007786
• UDI-Public: (01)00616258007786
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: 09/19/2024
• Device Model Number: 60728591
• Device Catalogue Number: SSQK 65/115VS
• Device Lot Number: 8411794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1