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

Model Number 405727

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/07/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 254665371
• Report Number: 1625685-2021-00042
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904057275
• UDI-Public: 00382904057275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1