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 Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/09/2019
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the tray epid cont we18g3.5 c20 lor5 s/l/l-e has been found experiencing inability for the catheter to thread the needle and packaging issues during use.The following has been provided by the initial reporter: material no:406047 batch no: unknown.It was reported that catheter was missing, syringes were sticking or the overall packing made it difficult to open the tray in a sterile fashion.Also at times the catheter was placed such that when you picked up the sterile drapes, the catheter would drop to the floor.It was also reported that the catheter is difficult to pass through the needle.Per customer email: i spoke to you a few months ago about the packaging of the epidural trays.My concerns were that sometimes the catheter was missing, syringes were sticking or the overall packing made it difficult to open the tray in a sterile fashion.Also at times the catheter was placed such that when you picked up the sterile drapes, the catheter would drop to the floor.In the past few months i have continued to have some of the same problems listed above but now have a much more serious safety issue.The catheter is difficult to pass thru the needle leading me to believe that the needle id or the catheter od is out of tolerance.The problem has continued to get worse over time to the point that this past week i could not pass the catheter much past the hub.I had to remove the needle from the patient and after trying unsuccessfully to pass the catheter thru the needle an arrow tray was used to place the epidural in the patient.This particular tray is in materials management for your inspection.This is a tray that i have used for well over 20 years and have always liked it over many other options.However, the qa of this item is no longer at the level where i can continue to use it without some serious changes to the quality control of this item.I currently have the same tray and did not have any catheter issues this week.However, the last time in l was here in late july i experienced similar problems where the catheter was difficult to pass thru the needle.While this could be a problem with a particular lot number i am very suspicious that this is a qa issue involving the tolerances for the needle and or catheter.
Event or Problem Description
It has been reported that the tray epid cont we18g3.5 c20 lor5 s/l/l-e has been found experiencing inability for the catheter to thread the needle and packaging issues during use.The following has been provided by the initial reporter: material no:406047 batch no: unknown.It was reported that "catheter was missing, syringes were sticking or the overall packing made it difficult to open the tray in a sterile fashion.Also at times the catheter was placed such that when you picked up the sterile drapes, the catheter would drop to the floor." it was also reported that the catheter is difficult to pass through the needle.Per customer email: i spoke to you a few months ago about the packaging of the epidural trays.My concerns were that sometimes the catheter was missing, syringes were sticking or the overall packing made it difficult to open the tray in a sterile fashion.Also at times the catheter was placed such that when you picked up the sterile drapes, the catheter would drop to the floor.In the past few months i have continued to have some of the same problems listed above but now have a much more serious safety issue.The catheter is difficult to pass thru the needle leading me to believe that the needle id or the catheter od is out of tolerance.The problem has continued to get worse over time to the point that this past week i could not pass the catheter much past the hub.I had to remove the needle from the patient and after trying unsuccessfully to pass the catheter thru the needle an arrow tray was used to place the epidural in the patient.This particular tray is in materials management for your inspection.This is a tray that i have used for well over 20 years and have always liked it over many other options.However, the qa of this item is no longer at the level where i can continue to use it without some serious changes to the quality control of this item.I currently have the same tray and did not have any catheter issues this week.However, the last time in l was here in late july i experienced similar problems where the catheter was difficult to pass thru the needle.While this could be a problem with a particular lot number i am very suspicious that this is a qa issue involving the tolerances for the needle and or catheter.
Additional Manufacturer Narrative
H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Dhr could not be performed as the lot# is unknown.

• 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: 8931501
• Report Number: 1625685-2019-00095
• Device Sequence Number: 2609583
• Product Code: CAZ
• UDI-Device Identifier: 00382904060473
• UDI-Public: 00382904060473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 09/12/2019

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: Other
• Device Catalogue Number: 406047
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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