MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT

Catalog Number	405672
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tray spn whit25g3.5 l/b-d/e blue drape experienced foreign matter, contaminated.The following information was provided by the initial reporter: piece of fiber in the syringe.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: two photos along with the physical sample were provided to our quality team for investigation.Through visual inspection of the physical sample, a plastic fiber was observed inside the syringe, verifying the reported incident.A review of the internal manufacturing device records and raw material history files for reported lot 0001517819 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.This syringe is provided by another bd site who has been notified of this incident.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that the tray spn whit25g3.5 l/b-d/e blue drape experienced foreign matter, contaminated.The following information was provided by the initial reporter: piece of fiber in the syringe.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17914634
• Report Number: 1625685-2023-00103
• Device Sequence Number: 6777232
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: (01)00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: Other
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 405672
• Device Lot Number: 0001517819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown