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

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 09/09/2019

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 an inconsistent latex free labelling on the lid of the stock. The lid shows both "latex free" and "contains latex" labelling. The issue was detected during incoming inspection/inventory review.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 9072479
• MDR Text Key: 167010560
• Report Number: 3006425876-2019-00728
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/16/2019
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device Catalogue Number: CA-11142-A
• Device LOT Number: 71F18J0795
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 09/21/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial