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

Model Number	60728699
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information, we are unable to determine the root cause of the unknown particles 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 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.Note: reference the following report numbers for related reports: 2520313-2017-00003.2520313-2017-00004.
Additional Manufacturer Narrative
Bayer product analysis received and examined 15 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 did not confirm the presence of the reported particulates.Product analysis determined that, during shipping/handling, movement of the syringes against the tyvek covers 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.

• 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: 6245367
• Report Number: 2520313-2017-00005
• Device Sequence Number: 16281524
• Product Code: DXT
• UDI-Device Identifier: 10616258005178
• UDI-Public: (01)10616258005178(11)161026(17)201026(10)8522842
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2017

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: Health Professional
• Device Expiration Date: 10/26/2020
• Device Model Number: 60728699
• Device Catalogue Number: SDS-CTP-QFT
• Device Lot Number: 8522842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1