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

Catalog Number JC-05400-LB

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The device is leaking due to a miniscule tear or hole.The catheter was removed and replaced.The patient's condition was reported as fine.

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, one flat filter, one epidural catheter, one non-teleflex 12ml luer slip syringe, and lidstock.The catheter, snaplock adapter, and flat filter were received connected together (reference attached files (b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock adapter appears typical with no observed defects or anomalies.Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical.Microscopic examination after a functional leak test revealed that the catheter has two cuts in the extrusion material approximately 25cm (ruler (b)(4)) from the proximal end (reference files (b)(4)).No other defects or anomalies were observed.The customer also submitted a photo.Other remarks: a functional leak test was performed per (b)(4) section 6.5 rev.5 using the returned catheter and snaplock adapter with the lab leak tester ((b)(4)).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 two cuts in the catheter extrusion material approximately 25cm from the distal 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 two cuts in the extrusion material approximately 25cm 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

The device is leaking due to a miniscule tear or hole.The catheter was removed and replaced.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6061885
• MDR Text Key: 58612730
• Report Number: 3006425876-2016-00333
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: JC-05400-LB
• Device Lot Number: 71F16A0577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention