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

Catalog Number JC-05400-E

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(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 bandage made to hold the catheter was humid after insertion of the epidural catheter; there was a leak.The device was replaced.There was no patient injury.

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 snaplock adapter with clip, one flat filter, and one epidural catheter.The components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned flat filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned snaplock adapter revealed the cap catheter adapter was not connected to the snaplock as it appears to have been broken off.Visual examination of the returned catheter revealed that the catheter appears used as adhesive material can be seen on the outer extrusion and biological material can be seen on the inner coils.Microscopic examination of the catheter revealed the catheter is damaged at approximately 25.5cm (c05158) from the distal end.Microscopic examination after a functional leak test revealed that the catheter has a small cut in the extrusion material approximately 27.5cm from the proximal end (reference files pic_anp1900061328).No other defects or anomalies were observed.A functional leak test was performed per mrq 000017 section 7.5 rev.7 using the returned catheter and a lab inventory snaplock adapter with the lab leak tester (c05176).The proximal end of the catheter was inserted into the 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 from a cut in the catheter extrusion material approximately 27.5cm from the proximal end.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 operational context caused or contributed to this event.The reported complaint of the catheter leaking was confirmed based on the sample received.The returned epidural catheter was confirmed to leak from a small cut in the extrusion material approximately 27.5cm from the proximal end.All epidural catheters are 100% 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 time of discovery and the condition of the sample received, operational context caused or contributed to this event.

Event Description

It was reported that the bandage made to hold the catheter was humid after insertion of the epidural catheter; there was a leak.The device was replaced.There was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7663705
• MDR Text Key: 113188637
• Report Number: 3006425876-2018-00401
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F18C1331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1