MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET: 19 GA; CATHETER, PERCUTANEOUS

Catalog Number EC-05400-E

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the drug leaked and could not be used properly.So the physician did not use it and he finished the procedure with teleflex's same product.The filters and the catheter were 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 medication was leaking from the catheter.The customer returned one opened kit (reference files (b)(4)).The epidural catheter was removed from the returned kit and visually examined with and without magnification.Visual examination of the returned catheter revealed that the catheter appears typical but used.Adhesive material can be seen on the outer extrusion of the catheter.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.No leak was detected coming from the catheter.Other remarks: the reported complaint of the catheter leaking could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.The returned catheter passed a functional leak test.There were no functional issues found with the returned catheter.

Event Description

It was reported that the drug leaked and could not be used properly.So the physician did not use it and he finished the procedure with teleflex's same product.The filters and the catheter were replaced.There was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 7128462
• MDR Text Key: 95252291
• Report Number: 3006425876-2017-00589
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K103658
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F16G1294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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