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

Model Number	86594218
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer radiology product analysis received and examined the returned solaris mr syringe kit and identified the presence of a white plastic particulate in the fluid path of the syringe barrel.The particulate was detected in the barrel of the syringe and measured approximately 3.2mm in length.Visual examination of the contrast spike found a small void space of material on the inner wall of the contrast spike luer.Our investigation determined that the particulate noted in the syringe was most likely flash from the inner wall of the contrast spike luer which occurred during the component manufacturing process.A 12 month review of complaint history determined the complaint rate to be (b)(4) complaints per million (cpm).
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 syringe barrel.The customer elected not to use the disposable kit.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: 12365600
• Report Number: 2520313-2021-00032
• Device Sequence Number: 4418125
• Product Code: DXT
• UDI-Device Identifier: 00616258021607
• UDI-Public: (01)00616258021607
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K012950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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 Model Number: 86594218
• Device Catalogue Number: SSQK 65/115VS
• Device Lot Number: 8417092
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1