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

Model Number	IPN913391
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "end user reported that while the goal of the blocker is to only have 1 cuff inflated to isolate, they were unable to do so potential to be user error as the lumens to inflate the cuffs are independent of each other so inflating one would not effect the other being inflated or not.It was not possible to have only one of the balloons inflated".No patient injury or harm reported.Additional device was used.Unknown patient condition at time of report.
Additional Manufacturer Narrative
Qn#: (b)(4).The actual sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports that a visual exam was performed and no defects were observed.Functional testing was also performed 15ml of air was let in the balloon on the yellow extrusion through the yellow pilot valve and after approximately 60 minutes the blue pilot valve and the balloon on the blue extrusion started slowly inflating.A device history record review was performed and no relevant findings were identified.The manufacturing site reports that the complaint was confirmed.The root cause is listed as supplier related.A non-conformance was opened to address this issue.
Event or Problem Description
It was reported "end user reported that while the goal of the blocker is to only have 1 cuff inflated to isolate, they were unable to do so potential to be user error as the lumens to inflate the cuffs are independent of each other so inflating one would not effect the other being inflated or not.It was not possible to have only one of the balloons inflated".No patient injury or harm reported.Additional device was used.Unknown patient condition at time of report.

• Brand Name: EZ-BLOCKER KIT
• Common Device Name: EZ BLOCKER
• MDR Report Key: 11546607
• Report Number: 3006425876-2021-00248
• Device Sequence Number: 4087986
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/02/2021

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: 07/21/2022
• Device Model Number: IPN913391
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 71F20G1864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• 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