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	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that" prior to use on patient, the customer did functional test and found balloon leakage".No patient involvement reported.
Event or Problem Description
It was reported that" prior to use on patient, the customer did functional test and found balloon leakage".No patient involvement reported.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was returned by the customer and sent to the manufacturing site for investigation.A device history record review was performed and no relevant findings were identified.The manufacturing site reports "the reported defect cannot be confirmed because the defective device was returned without catheter where the defective cuffs/balloons are presented".A complete investigation could not be performed as an incomplete device was returned; therefore, a root cause could not be identified.

• Brand Name: EZ-BLOCKER KIT
• Common Device Name: EZ BLOCKER
• MDR Report Key: 12124354
• Report Number: 3006425876-2021-00594
• Device Sequence Number: 14293213
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K121462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 07/15/2022
• Device Model Number: IPN913391
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 71F20G1092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 09/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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