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

Model Number	86698153
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2002
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer radiology product analysis reviewed the information and photographs that were provided.Visual examination identified the presence of a hair-like particulate of unknown etiology within the barrel of the syringe.Our investigation determined that the particulate noted in the syringe was likely introduced during the component manufacturing or assembly process.A 12 month review of complaint history determined the complaint rate to be 0.26 complaints per million (cpm).
Event or Problem Description
The site reported the following: after filling the ct syringe with saline, the technologist noticed a thin, hair-like foreign body within the syringe barrel.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: 12248827
• Report Number: 2520313-2021-00029
• Device Sequence Number: 4599621
• Product Code: DXT
• UDI-Device Identifier: 00616258022086
• UDI-Public: (01)00616258022086
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/29/2021

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: 03/16/2025
• Device Model Number: 86698153
• Device Catalogue Number: SDS-CTP-QFT
• Device Lot Number: 8589543
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1