MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6" CATHETER INTRAVASCULAR THERAP

Catalog Number CDC-42703-P1A

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Information obtained from maude report (mw5082351/mdr report key (b)(4)). The report does not have any additional information or contact information.

Event Description

According to the maude report (mw5082351/mdr report key (b)(4)) the md was attempting to place a triple lumen in a critical patient when the introducer wire made a 90-degree bend and could not be advanced (mdr# 9680794-2019-00026). A second triple lumen kit was opened and had a problem with this wire (mdr #9680794-2019-00027). The wire in the second kit was stripped. Both kits were unusable. A different product was used successfully.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8281405
• MDR Text Key: 134333211
• Report Number: 9680794-2019-00027
• 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: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Catalogue Number: CDC-42703-P1A
• Device Lot Number: 13F18D0506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial