MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; CATHETER, INTRODUCER

Catalog Number CA-11142-A

Device Problems Device Damaged Prior to Use (2284); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device (with catalog# ca-11142-a) is not intended for sale in the us.Similar device/component sold in the us.

Event Description

The customer reports: conflicting information regarding product containing latex.Sticker label on packaging says latex free and package label says contains latex.The issue was noticed by the staff prior to insertion.

Manufacturer Narrative

(b)(4).The sample was not returned; however, the customer provided one photo of part of the product lidstock for lot#: 71f18j0795 for evaluation.Visual examination of the photo confirmed the lidstock said both "contains latex" and "latex free." a device history record review was performed and no relevant findings were identified.The customer reported issue of "latex" and "latex-free" on the lidstock was confirmed through visual examination of the customer-supplied photo.This misprint occurred during the packaging process; therefore, the probable root cause of this issue is packaging related.A non-conformance request has been initiated to further investigate this issue.

Event Description

The customer reports: conflicting information regarding product containing latex.Sticker label on packaging says latex free and package label says contains latex.The issue was noticed by the staff prior to insertion.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Type of Device: CATHETER, INTRODUCER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9037302
• MDR Text Key: 167021433
• Report Number: 3006425876-2019-00725
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: CA-11142-A
• Device Lot Number: 71F18J0795
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1