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

Model Number	60728753
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer radiology product analysis received and examined the returned syringe kit.Visual examination confirmed the presence of white particles on the syringe barrel near the drip flange.Also noted were abrasions to the tyvek cover at the point of contact for the syringe drip flange.Product analysis determined that, during shipping/handling, movement of the syringe against the tyvek cover caused adhesive material to flake off the cover and settle within the disposable container as well as on the surface of the syringe assembly.A 12 month review of complaint history determined the complaint rate to be (b)(4) complaints per million (cpm).
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.The customer elected not to use the syringe kit.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: 9852888
• Report Number: 2520313-2020-00012
• Device Sequence Number: 19499109
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

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: 11/13/2022
• Device Model Number: 60728753
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8552826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1