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

Model Number	IPN913391
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Decreased Peak Expiratory Flow rate (2435)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#:(b)(4).
Event or Problem 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 or Problem 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".
Additional 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
• Common Device Name: EZ BLOCKER
• MDR Report Key: 11723208
• Report Number: 3006425876-2021-00357
• Device Sequence Number: 14452656
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1