MAUDE Adverse Event Report: EZ-BLOCKER KIT; EZ BLOCKER

Model Number IPN913391

Device Problem Inflation Problem (1310)

Patient Problem Decreased Peak Expiratory Flow rate (2435)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#:(b)(4).

Event Description

It was reported "we had an issue with one of the blockers.When we inflate one.Over time the other also inflated".No patient harm or injury reported.Patient condition reported as "fine".

Event Description

It was reported "we had an issue with one of the blockers when we inflate one over time the other also inflated".No patient harm or injury reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The actual device was not returned; however, the customer provided photos for evaluation.The manufacturing site reports that a visual exam was performed on the photos and the defect was confirmed.The manufacturing site also reports that the issue is crossover on the ez blocker catheter.The issue is supplier related and a non-conformance was previously opened to address this issue.Corrective actions have been implemented.This lot was produced prior to the implementation of corrective actions.

• Brand Name: EZ-BLOCKER KIT
• Type of Device: EZ BLOCKER
• MDR Report Key: 11723208
• MDR Text Key: 247242152
• Report Number: 3006425876-2021-00357
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (y/n): N
• PMA/PMN Number: K121462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/28/2022
• Device Model Number: IPN913391
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 71F20G2461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1