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

Model Number	60728753
Medical Device Problem Codes	Product Quality Problem (1506); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject disposable kit has been retained by the customer and will not be returned to bayer for evaluation.Bayer radiology product analysis reviewed the information and photographs that were provided.Visual examination confirmed the presence of a black hair-like particulate, which appeared to be suspended in the fluid filled syringe.Our investigation determined that the particulate was most likely introduced during the manufacturing 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 site reported the following: after filling the ct disposable syringe with saline, the technologist noticed a thin, hair-like foreign body within the syringe barrel.The customer elected not to use the 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: 7436802
• Report Number: 2520313-2018-00038
• Device Sequence Number: 1677876
• Product Code: DXT
• UDI-Device Identifier: 00616258007939
• UDI-Public: (01)00616258007939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 12/07/2021
• Device Model Number: 60728753
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8538695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1