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	Break (1069)
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
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
Material no.: 406047.Batch no.: 0001285103.It was reported that during use of the tray epid cont we18g3.5 c20 lor5 s/l/l-e the doctor had difficulty getting the catheter through the needle.It was stated that the package says it is a 20 gauge catheter but it is actually a 19 gauge catheter and it does not fit through the 18 gauge needle.The following information was provided by the initial reporter: i now have a lot # as it has happened a couple of more times.Lot #0001285103.Three times yesterday and once this morning.I am pulling all trays of this lot # from service.
Additional Manufacturer Narrative
Investigation: sample analysis verified the failure mode (incorrect component).Thirteen (13) of the nineteen (19) samples returned contained the incorrect 19 gauge epidural catheter (blue label).Six (6) of the nineteen samples contained the correct 20 gauge epidural catheter (white label).The investigation noted that packaging of the product 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.
Event or Problem Description
Material no.: 406047 batch no.: 0001285103.It was reported that during use of the tray epid cont we18g3.5 c20 lor5 s/l/l-e the doctor had difficulty getting the catheter through the needle.It was stated that the package says it is a 20 gauge catheter but it is actually a 19 gauge catheter and it does not fit through the 18 gauge needle.The following information was provided by the initial reporter: i now have a lot # as it has happened a couple of more times.Lot #0001285103.Three times yesterday and once this morning.I am pulling all trays of this lot # from service.

• 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: 8896890
• Report Number: 1625685-2019-00092
• Device Sequence Number: 18925412
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 406047
• Device Lot Number: 0001285103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/15/2019
• 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