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

Model Number	84192961
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined one returned spike.Visual examination confirmed the presence of a particle within the tip of the spike cover.Further examination determined that the particle was partially connected to the inside of the cover.As the particle was partially embedded into the cover wall, there is a potential that it could fragment and enter the fluid path.Our investigation determined that the particle noted in the spike cover was introduced during the manufacturing process and was not detected upon receipt of the product from the supplier.(b)(4).
Event or Problem Description
The customer reported the following: after opening the stellant ct disposable kit and upon inspection, they saw a foreign body within the cover of the spike.The customer elected not to use the disposable kit.No injury or adverse event was reported.
Additional Manufacturer Narrative
Corrected data from initial report: the initial mdr dated august 6, 2018 was submitted with information stating that there was a possibility that the particulate could fragment and enter the fluid path.After further examination, the particulate was confirmed to be partially embedded within the tip of the spike cover which is a significant distance away from the spike tip.The spike cover is discarded prior to use.No pressure is generated while the cover is on the spike; therefore, the potential that the particulate could fragment and enter the fluid path does not exist.

• 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: 7752278
• Report Number: 2520313-2018-00055
• Device Sequence Number: 1567772
• Product Code: DXT
• UDI-Device Identifier: 00616258007045
• UDI-Public: (01)00616258007045
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: 06/03/2022
• Device Model Number: 84192961
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8548319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1