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

Catalog Number AB-19608-S

Device Problems Kinked (1339); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician reported that the catheter tip kinks closed and makes infusion impossible.The patient's condition is unknown at this time.

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the stimucath catheter with no relevant findings.The customer reported the catheter the catheter tip kinks and infusion is impossible.The customer retuned one adaptor catheter and one stimucath catheter.The components were received connected together.Visual examination of the returned adaptor catheter revealed the adapter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the tip at the distal end is slightly bent as compared to a lab inventory.No other defects or anomalies were observed.A manual flow test was performed using the returned catheter and adapter catheter.A 20ml lab inventory syringe was connected to the returned components.Using hand pressure, the water was injected.Water could be seen immediately exiting the distal end of the catheter.No blockages were found.Also, a catheter stylet was fully inserted into the catheter with no resistance met.The reported complaint of the catheter being kinked and medication not injecting through could not be confirmed based on the sample received.A device other remarks: history record review was performed on the stimucath catheter with no evidence to suggest a manufacturing related issue.Although the returned distal tip was slightly bent compared to a lab inventory catheter, the returned catheter passed a functional flow test and a stylet could be fully inserted with no resistance met.Therefore, based on this, no functional issues found with the returned sample.

Event Description

The physician reported that the catheter tip kinks closed and makes infusion impossible.The patient's condition is unknown at this time.

• 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: 6784585
• MDR Text Key: 82668009
• Report Number: 9680794-2017-00139
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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: AB-19608-S
• Device Lot Number: 14F16G0597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2016
• 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