MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. STELLANT CT SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT

Model Number	86698153
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned suspect syringe.Visual examination confirmed the presence of a white colored particle within the fluid path.The particle was identified as a mold gate fiber that was introduced during the manufacturing process.Our investigation determined that the particle noted in the syringe was introduced during the manufacturing process and was not detected upon receipt of the product from the supplier.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 foreign material was observed in a stellant syringe.No injury or adverse event was reported.

• Brand Name: STELLANT CT SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 12128167
• Report Number: 2520313-2021-00023
• Device Sequence Number: 3592078
• Product Code: DXT
• UDI-Device Identifier: 00616258022086
• UDI-Public: (01)00616258022086
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K082905
• 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): 07/07/2021

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: 05/20/2025
• Device Model Number: 86698153
• Device Catalogue Number: SDS-CTP-QFT
• Device Lot Number: 8597180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1