MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW TELEFLEX; CENTRAL VENOUS CATHETER

Model Number N/A

Device Problems Material Frayed (1262); Sticking (1597); Failure to Advance (2524); Difficult to Open or Close (2921)

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

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016 resource optimization and innovation a convenience kit manufacturer was notified through customer service of a complaint logged by (b)(6) from (b)(6), regarding the needle holder within a teleflex arrow catheter kit not closing properly.After contacting the customer to further investigate the initial complaint that did not contain information noting any patient harm, further correspondence showed potential patient harm from prolonged procedure time, canceled and rescheduled procedure and risk of infection from repeat procedures.Other concerns noted in subsequent communications include: the guide wire fraying apart when being removed from patient, guide wire not advancing or will advance but cannot then remove the needle back over the lead wire because it gets stuck.

Event Description

Needle holder within teleflex arrow catheter kit is not closing properly, guide wire frayed, lead wire won't advance or gets stuck once advanced and won't pull back.Contained in a roi convenience kit as a component (finished device) in kit lawson # (b)(4) (max barrier central line kit trpl lumen 20cm) lot - 037938b.

• Brand Name: ARROW TELEFLEX
• Type of Device: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; 315 carrington mill blvd.; morrisville NC 27560
• Manufacturer (Section G): ROI, CONSOLDATED SERVICE CENTER (CSC); 2909 north neergard avenue; springfiled MO 65803
• Manufacturer Contact: robert callahan ; 2902 north neergard; springfield, MO 65802 ; 3143646561
• MDR Report Key: 6243081
• MDR Text Key: 65027142
• Report Number: 3004513970-2016-00001
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902117219
• UDI-Public: 10801902117219
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/06/2017

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: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F16F0796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 6 MO
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1