MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUCATH SET: 19G CATH, 17G X 8CM NDL; ANESTHESIA CONDUCTION KIT

Catalog Number AB-19608-S

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2016

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

Reported event: there was no connection detected from nerve stimulation with 19ga x 60cm stimucath continuous nerve block catheter.Confirmed no connection with second nerve stimulator; opened a second kit and achieved contact with catheter in that kit.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.The potential cause of no connection detected from the nerve stimulator could not be determined based upon the information provided and without a sample.

Event Description

Reported event: there was no connection detected from nerve stimulation with 19ga x 60cm stimucath continuous nerve block catheter.Confirmed no connection with second nerve stimulator; opened a second kit and achieved contact with catheter in that kit.The patient's condition was reported as fine.

• Brand Name: STIMUCATH SET: 19G CATH, 17G X 8CM NDL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5672632
• MDR Text Key: 46201621
• Report Number: 9680794-2016-00063
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: AB-19608-S
• Device Lot Number: 14F15K0085
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• 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