MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT

Model Number IPN046311

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the catheter is leaking.

Event Description

It was reported that the catheter is leaking.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was leaking.The customer returned one epidural catheter (reference attached files (b)(4)).The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on the inner coils and adhesive can be seen on the outer extrusion.Microscopic examination of the catheter revealed the catheter is damaged at approximately 28.5cm (100171599) from the proximal end.The extrusion appears to have a hole (reference files (b)(4)).No other damage was observed.A functional leak test was performed per amrq-000017 section 7.5 rev.7 using the returned catheter with the lab leak tester (c05176).The proximal end of the catheter was inserted into a lab inventory snaplock adapter until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock adapter was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from the same location where the catheter was cut at 28.5cm from the proximal end, which was revealed during the visual inspection.No other leaks were detected.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.All epidural catheters are tested for leaks at the time of manufacturing.A device history record review performed on the epidural catheter showed no evidence to suggest a manufacturing related cause.The leak was detected during use.Therefore, based on the condition of the sample received and the time of discovery indicate unintentional user error caused or contributed to this event.The reported complaint of the catheter leaking was confirmed based on the sample received.During the functional inspection, the returned epidural catheter was confirmed to leak from where the catheter was damaged at approximately 28.5cm from the proximal end.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The leak was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9382387
• MDR Text Key: 179123579
• Report Number: 3006425876-2019-00999
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2021
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19F0481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1