MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT27G3.5; ANESTHESIA CONDUCTION KIT

Model Number	405727
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Pma/510(k)#: enforcement discretion.
Event or Problem Description
It was reported that tray spn whit27g3.5 had foreign matter.The following information was provided by the initial reporter: it was reported foreign material.Verbatim: customer states they have found particles in their anesthesia trays.Anesthesiologist threw the tray to the side in disgust.
Additional Manufacturer Narrative
The following fields were corrected: d10: device available for eval: no.H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A device history review was performed for the reported lot 0001392977, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the quality team's investigation and without the physical sample for evaluation we cannot identify the origin of the matter that was observed, therefore, a definitive root cause cannot be established at this time.
Event or Problem Description
It was reported that tray spn whit27g3.5 had foreign matter.The following information was provided by the initial reporter: it was reported foreign material.Customer states they have found particles in their anesthesia trays.Anesthesiologist threw the tray to the side in disgust.

• Brand Name: TRAY SPN WHIT27G3.5
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11943538
• Report Number: 1625685-2021-00042
• Device Sequence Number: 4066298
• Product Code: CAZ
• UDI-Device Identifier: 00382904057275
• UDI-Public: 00382904057275
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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: Other
• Device Model Number: 405727
• Device Catalogue Number: 405727
• Device Lot Number: 0001392977
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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