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

Model Number	85233084
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned solaris mr disposable syringe kit.Visual examination of the 115 ml syringe barrel confirmed the presence of a white, circular shaped particle of unknown etiology within the fluid path.The particle was detected in the barrel of the syringe and measured approximately 1.72 mm by 1.8 mm.Our investigation determined that the particle noted in the syringe was likely introduced during the component manufacturing process.(b)(4).
Event or Problem Description
The customer reported the following: after filling the solaris mr disposable saline syringe and upon inspection, they saw an unknown particulate within the syringe assembly.The customer elected not to use the product.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: 12666364
• Report Number: 2520313-2021-00038
• Device Sequence Number: 4869198
• Product Code: DXT
• UDI-Device Identifier: 00616258010021
• UDI-Public: (01)00616258010021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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 Expiration Date: 12/11/2025
• Device Model Number: 85233084
• Device Catalogue Number: SSQK 115
• Device Lot Number: 8415161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1