MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 22GAX6CM CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00622-B

Device Problems Fluid Leak (1250); Gas Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint description: after insertion when the needle and guidewire were removed, the port the needle and guidewire come out of did not seal. When flushed, fluid leaded out and when aspirated air was being sucked in. Used a different lot number without any issues.

• Brand Name: ARROW EXT DWELL CATH BASIC 22GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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 ; 9194334854
• MDR Report Key: 8712059
• MDR Text Key: 148424268
• Report Number: 9680794-2019-00236
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2020
• Device Catalogue Number: EDC-00622-B
• Device Lot Number: 13F18K0331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial