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

Model Number	60728699
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer quality assurance product analysis received and examined the returned lpct, lot #8532055.The defect was identified as degraded compound (resin) that is partially embedded in the tubing wall and extends into the fluid pathway.The cause of the reported problem is degraded compound (resin) that collected on the extrusion tooling and became partially embedded in the tubing as it was formed during manufacturing.A 12 month review of complaint history determined the frequency to be (b)(4) complaints per million (cpm) for similar defects.
Event or Problem Description
The site reported the following: a foreign body that "looks like a gnat" was visualized in the low pressure connecting tubing set (lpct).This was observed prior to use and the tubing was never used on a patient.

• Brand Name: STELLANT CT SYRINGE KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PA 15051
• MDR Report Key: 6817755
• Report Number: 2520313-2017-00056
• Device Sequence Number: 10800543
• Product Code: DXT
• UDI-Device Identifier: 00616258005171
• UDI-Public: (01)00616258005171
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2021
• Device Model Number: 60728699
• Device Catalogue Number: SDS-CTP-QFT
• Device Lot Number: 8532055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1