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

Model Number	60729369
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	No Patient Involvement (2645); Not Applicable (3189)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned spike.Visual examination confirmed the presence of a foreign material on the spike.Our investigation determined that the foreign material was most likely introduced during the manufacturing process at the third-party supplier and went undetected.A 12-month review of complaint history determined the complaint rate to be 0.52 complaints per million (cpm).
Event or Problem Description
The customer reported the following: after opening the stellant ct disposable kit the customer observed a foreign material on the spike.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: 9412789
• Report Number: 2520313-2019-00058
• Device Sequence Number: 14194686
• Product Code: DXT
• UDI-Device Identifier: 00616258005256
• UDI-Public: (01)00616258005256
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 10/12/2023
• Device Model Number: 60729369
• Device Catalogue Number: SDS-CTP-SCS
• Device Lot Number: 8568613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1