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

Model Number	86698188
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined one returned stellant ct disposable kit, lot number 8590469.Visual examination confirmed the presence of an unknown black residue that was partially connected to the inside wall of the luer connector.Our investigation determined that the residue noted in the connector was most likely introduced during the manufacturing process and was not detected upon receipt of the product from the supplier.A 12 month review of complaint history determined the complaint rate to be (b)(4).
Event or Problem Description
The customer reported the following: after opening the stellant ct disposable kit and upon inspection, they saw an unknown particulate within the male luer connector of the low pressure connector tubing (lpct).The customer elected not to use the tubing.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: 11343696
• Report Number: 2520313-2021-00006
• Device Sequence Number: 19685287
• Product Code: DXT
• UDI-Device Identifier: 00616258022130
• UDI-Public: (01)00616258022130
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/18/2021

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: 12/29/2024
• Device Model Number: 86698188
• Device Catalogue Number: SDS-CTP-SPK
• Device Lot Number: 8590469
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1