MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E; ANESTHESIA CONDUCTION KIT

Catalog Number	406047
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of tray epid cont we18g3.5 c20 lor5 s/l/l-e experienced a mix of product types in a pack which was noted prior to use.The following information was provided by the initial reporter: material no: 406047 batch no: 0001285103.Voicemail received which mentioned an issue with item 406047.The voicemail cut in an out but it seems that one of the components in the tray is not correct.
Additional Manufacturer Narrative
Investigation summary: dhr: a review of the device history records identified no issues for lot 0001285103.No samples were returned for analysis.The investigation noted that packaging of the 406047 is a manual process.As part of this manufacturing process, all components are to be verified with the applicable bill of material at start up and at any time during the manufacturing process when more components are delivered to the manufacturing line.The investigation identified the most probable root cause to be a failure in the component verification step with the applicable bill of materials during the manufacture of the affected finished good lot.
Event or Problem Description
It was reported that an unspecified number of tray epid cont we18g3.5 c20 lor5 s/l/l-e experienced a mix of product types in a pack which was noted prior to use.The following information was provided by the initial reporter: material no: 406047 batch no: 0001285103 voicemail received which mentioned an issue with item 406047.The voicemail cut in an out but it seems that one of the components in the tray is not correct.

• Brand Name: TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8838906
• Report Number: 1625685-2019-00079
• Device Sequence Number: 11311730
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (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): 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 406047
• Device Lot Number: 0001285103
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other