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

Model Number	60728737
Medical Device Problem Codes	Product Quality Problem (1506); Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned sds-ctp-spk kit.Visual examination confirmed the presence of a foreign material that is white in color, pliable and appears to be plastic or vinyl material.This particulate was likely introduced during the component manufacturing or assembly.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 technologist placed the syringes from an sds-ctp-spk kit (lot number 8533438) on the injector and prior to filling the syringes he noticed a piece of plastic inside one of the syringe barrels.The syringes were immediately removed and not used for 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: 6879250
• Report Number: 2520313-2017-00060
• Device Sequence Number: 659851
• Product Code: DXT
• UDI-Device Identifier: 00616258005188
• UDI-Public: (01)00616258005188(11)170701(17)210701
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/20/2017

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: 07/01/2021
• Device Model Number: 60728737
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8533438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1