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

Model Number	IPN913391
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "ez blocker bronchial blocker size 7 fr was found with yellow cuff leaking during procedure".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The actual sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports that functional testing was performed and it was found that the balloon on the yellow extrusion was leaking.The complaint is confirmed; however, a root cause for the issue could not be identified.
Event or Problem Description
It was reported that "ez blocker bronchial blocker size 7 fr was found with yellow cuff leaking during procedure".No patient involvement reported.

• Brand Name: EZ-BLOCKER KIT
• Common Device Name: EZ BLOCKER
• MDR Report Key: 11584688
• Report Number: 3006425876-2021-00249
• Device Sequence Number: 11807712
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 08/04/2022
• Device Model Number: IPN913391
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 71F20H0167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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