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

Model Number	86698188
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/09/2020
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.
Event or Problem Description
The customer reported the following: after opening the stellant ct disposable kit and upon inspection, they saw a foreign particle within the syringe barrel.The customer elected not to use the syringe.No injury or adverse event was reported.
Additional Manufacturer Narrative
Bayer radiology product analysis received and examined the returned syringe assembly.Visual examination confirmed the presence of a white hair-like particulate within the syringe barrel neck.Our investigation determined that the particulate was a mold gate fiber that was introduced during the manufacturing process and was not detected upon receipt of the syringe from the supplier.A 12 month review of complaint history determined the complaint rate to be 0.49 complaints per million (cpm).

• 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: 9868353
• Report Number: 2520313-2020-00014
• Device Sequence Number: 3268066
• Product Code: DXT
• UDI-Device Identifier: 00616258022130
• UDI-Public: (01)00616258022130
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 01/30/2024
• Device Model Number: 86698188
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8576343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention