MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2 CATHETER INTRAVASCULAR THERAP

Catalog Number CDC-45703-P1A

Device Problem Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 03/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reports issue with guidewire unraveling while pulling from the central line/introducer. There was no report of patient harm.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14197455
• MDR Text Key: 290057397
• Report Number: 9680794-2022-00250
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-45703-P1A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial