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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; 315 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6243081
• Report Number: 3004513970-2016-00001
• Device Sequence Number: 439721
• Product Code: FOZ
• UDI-Device Identifier: 10801902117219
• UDI-Public: 10801902117219
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Device Age: 6 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1