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

Model Number	60728591
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the following: a white foreign body was found inside the syringe upon opening a new ssqk65/115vs syringe kit.No injury or adverse event was reported.
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned mr disposable syringe kit.Visual examination of the syringe barrel confirmed the presence of a white particle within the fluid path that was most likely material from the inner wall of the contrast spike luer which occurred during the component manufacturing/assembly process.A 12 month review of complaint history determined the complaint rate to be (b)(4) complaints per million (cpm).

• 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
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: susan sherwin ; 1 bayer drive; indianola, PA 15051 ; 7249408678
• MDR Report Key: 13177739
• Report Number: 2520313-2022-00003
• Device Sequence Number: 4620920
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2022

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: 05/07/2026
• Device Model Number: 60728591
• Device Catalogue Number: SSQK65/115VS
• Device Lot Number: 8417225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown