MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL NEEDLE COMPONENT

Catalog Number SJ-05501

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during attempted removal of the epidural catheter some of the catheter broke off in the patient's spine.

• Brand Name: EPIDURAL NEEDLE COMPONENT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 8175623
• MDR Text Key: 130916514
• Report Number: 1036844-2018-00312
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2017
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F16C0477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage