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

Catalog Number 406047

Device Problem Break (1069)

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

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the tray epid cont we18g3.5 c20 lor5 s/l/l-e catheter would not thread through the 18-gauge needle during use on a patient.Additionally, it was reported that the packaging stated the device was a "20 gauge" catheter, but the customer alleged it was "actually a 19 gauge catheter".This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "customer stated that the package say 20 gauge catheter, but is actually a 19 gauge catheter, and it does not fit through the 18 gauge needle.Customer states that the doctor had an issue this morning.Product was used on patient, but doctor had difficulty getting the catheter through the needle.".

Manufacturer Narrative

Investigation summary: 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).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.All applicable manufacturing associates have received awareness training regarding this particular incident.Dhr: a review of the device history records identified no issues for lot 0001285103.

Event Description

It was reported that the tray epid cont we18g3.5 c20 lor5 s/l/l-e catheter would not thread through the 18-gauge needle during use on a patient.Additionally, it was reported that the packaging stated the device was a "20 gauge" catheter, but the customer alleged it was "actually a 19 gauge catheter".This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "customer stated that the package say 20 guage catheter, but is actually a 19 gauge catheter, and it does not fit through the 18 gauge needle.Customer states that the doctor had an issue this morning.Product was used on patient, but doctor had difficulty getting the catheter through the needle.".

• Brand Name: TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8869710
• MDR Text Key: 153827077
• Report Number: 1625685-2019-00088
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other