MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. 200ML ODYSSEY SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT

Model Number	60728656
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined 2 returned syringe kits.Visual examination confirmed the presence of white particulates in each of the returned kits.Further evaluation determined that the white particulates were concentrated near the syringe drip flanges and there were traces of the particulates within the styrene tray.Also noted were abrasions to the tyvek covers at the point of contact for the syringe drip flanges.Examination of retained samples for this lot number confirmed the presence of the white particulates on the syringe barrels and within the styrene trays as well as abrasions to the tyvek covers.Product analysis determined that an abrasive action between the syringe drip flanges and the tyveks cover caused adhesive material to flake off of the cover and settle within the disposable container.The syringe kit instructions for use instructs the user to "visually inspect contents and package before each use".This visual inspection is to ensure particulates are noticed and mitigated, which is what occurred in this reported instance.
Event or Problem Description
The customer reported the following: after opening the envision ct disposable kit and upon inspection, they noticed the presence of fine white particles around the syringe as well as the quick fill tube (qft).The customer elected not to use the syringe kit.No injury or adverse event was reported.

• Brand Name: 200ML ODYSSEY SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 6285956
• Report Number: 2520313-2017-00007
• Device Sequence Number: 16288533
• Product Code: DXT
• UDI-Device Identifier: 10616258005437
• UDI-Public: (01)10616258005437(11)160914(17)210914(10)8403830
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K924116
• 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): 01/30/2017

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: Nurse
• Device Expiration Date: 09/14/2021
• Device Model Number: 60728656
• Device Catalogue Number: CTP-200-FLS
• Device Lot Number: 8403830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1