MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number OU-05500-NRON

Device Problem Activation, Positioning or SeparationProblem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The plunger of lor syringe did not slide during preparation for the procedure. Therefore, a new kit was opened instead.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11894465
• MDR Text Key: 256222353
• Report Number: 3006425876-2021-00518
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: OU-05500-NRON
• Device Lot Number: 71F20H3119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage