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 Patient Involvement (2645)
Date of Event	08/26/2019
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 2 trays epid cont we18g3.5 c20 lor5 s/l/l-e were found before use with 19g epidural catheters, rather than the 20g catheters indicated on the labeling.The following information was provided by the initial reporter: "our anesthesia group is coming across a component discrepancy.Bd continuous epidural tray 406047 is labeled as having a 20g x36 in epidural catheter.We have two trays that came with 19g.".
Event or Problem Description
It was reported that 2 trays epid cont we18g3.5 c20 lor5 s/l/l-e were found before use with 19g epidural catheters, rather than the 20g catheters indicated on the labeling.The following information was provided by the initial reporter: "our anesthesia group is coming across a component discrepancy.Bd continuous epidural tray 406047 is labeled as having a 20g x36 in epidural catheter.We have two trays that came with 19g.".
Additional Manufacturer Narrative
Investigation summary: sample analysis confirmed the failure mode (incorrect component).Five (5) of the seven (7) samples returned contained the incorrect 19 gauge epidural catheter (blue label).Two (2) of the seven (7) samples contained the correct 20 gauge epidural catheter (white label).A review of the device history records identified no issues for lot 0001285103.The investigation noted that packaging of the (b)(4) 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.Based on the dhr review results and the sample evaluation, 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.Conclusion: based on the complaint investigation, the most probable root cause was that manufacturing personnel did not properly verify components as they were delivered to the manufacturing line.Based on the identified probable root cause, all applicable manufacturing associates have received awareness training regarding this particular incident.

• 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: 8981156
• Report Number: 1625685-2019-00107
• Device Sequence Number: 14169929
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/16/2019

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 406047
• Device Lot Number: 0001285103
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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