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

Model Number	60728737
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer quality assurance product analysis received and examined the returned sds-ctp-spk syringe, lot # 8537339.Visual examination found excessive material extending from the syringe plunger tip.The excessive material was connected to the syringe tip, identified as molding flash and measured 3mm by 2mm.Our investigation determined that the particle noted in the syringe occurred during the supplier's manufacturing process and was not detected upon receipt of the syringe from the supplier.A 12 month review of complaint history determined the frequency to be (b)(4) complaints per million.
Event or Problem Description
The site reported the following: a foreign particle was detected inside of the ct syringe.The particle appeared to be black plastic on the tip of the plunger.

• 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: 7339351
• Report Number: 2520313-2018-00029
• Device Sequence Number: 13649482
• Product Code: DXT
• UDI-Device Identifier: 00616258005188
• UDI-Public: (01)00616258005188
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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: 11/13/2021
• Device Model Number: 60728737
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8537339
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1