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	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information, we are unable to determine the root cause of the unknown 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.This information does not constitute an admission that the device, the company or its employees caused or contributed to this reportable event.
Event or Problem Description
The customer reported the following: after opening the solaris disposable kit and upon inspection, they noticed a 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 product analysis received and examined the returned syringe kit.Visual examination confirmed the presence of two fully embedded and fully encased dark colored particulates within the syringe barrel material.Our investigation determined that the particles were introduced into the syringe barrel during the injection molding process.The particulates were completely embedded within the syringe barrel; therefore, the potential to further travel into the fluid path does not exist.

• 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: 9765509
• Report Number: 2520313-2020-00008
• Device Sequence Number: 16841113
• 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): 03/13/2020

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: 05/21/2024
• Device Model Number: 60728591
• Device Catalogue Number: SSQK 65/115VS
• Device Lot Number: 8411302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1