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	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer radiology product analysis reviewed a photo that was provided, and identified the presence of a thin strand of hair of unknown origin in the fluid path.Our investigation determined that the particulate noted in the syringe was likely introduced during the component manufacturing or assembly 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: a thin, hair-like foreign body of unknown origin was seen in the mr syringe.The customer elected not to use the syringe.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: 10619436
• Report Number: 2520313-2020-00036
• Device Sequence Number: 11442884
• Product Code: DXT
• UDI-Device Identifier: 00616258021607
• UDI-Public: (01)00616258021607
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/02/2020

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: 04/10/2025
• Device Model Number: 86594218
• Device Catalogue Number: SSQK 65/115VS
• Device Lot Number: 8413413
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1