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	07/23/2019
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
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.".
Additional 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 or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8869710
• Report Number: 1625685-2019-00088
• Device Sequence Number: 253845
• 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: 07/23/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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