MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID CONT WE17G3.5 SWC X3796; ANESTHESIA CONDUCTION KIT

Model Number 406151

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a hair was found in the tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter: "they found a hair in one of the anesthesia trays".

Event Description

It was reported that a hair was found in the tray epid cont we17g3.5 swc x3796.The following information was provided by the initial reporter: "they found a hair in one of the anesthesia trays.".

Manufacturer Narrative

Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.

• Brand Name: TRAY EPID CONT WE17G3.5 SWC X3796
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9504898
• MDR Text Key: 195559373
• Report Number: 1625685-2019-00143
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904061517
• UDI-Public: 00382904061517
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 406151
• Device Catalogue Number: 406151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other