MAUDE Adverse Event Report: CAREFUSION, INC BD 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	07/25/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the incorrect needle length was in the tray with a bd tray epid cont we18g3.5 c20 lor5 s/l/l-e.This occurred on 2 separate occasions prior to use.The following information was provided by the initial reporter: it was reported that two trays contained the incorrect needle length.Health care professional called to report that doctor found 2 kits that had 19 g instead of 20g lot is unknown.
Additional Manufacturer Narrative
Investigation: no samples were returned for analysis.The root cause could not be confirmed without a lot number or sample but 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.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 complaint investigation, the most probable root cause was that manufacturing personnel did not properly verify components as they were delivered to the manufacturing line.
Event or Problem Description
It was reported that the incorrect needle length was in the tray with a bd tray epid cont we18g3.5 c20 lor5 s/l/l-e.This occurred on 2 separate occasions prior to use.The following information was provided by the initial reporter: it was reported that two trays contained the incorrect needle length.Health care professional called to report that doctor found 2 kits that had 19 g instead of 20g lot is unknown.

• Brand Name: BD 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: 8895032
• Report Number: 1625685-2019-00090
• Device Sequence Number: 1658719
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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 Catalogue Number: 406047
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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