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	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "that the left cuff of the device was inflated by the user.During use this left cuff deflated and at the same time the right cuff (which was not inflated by the user) did inflate automatically".No patient harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "that the left cuff of the device was inflated by the user.During use this left cuff deflated and at the same time the right cuff (which was not inflated by the user) did inflate automatically".No patient harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: EZ-BLOCKER KIT
• Common Device Name: EZ BLOCKER
• MDR Report Key: 11364999
• Report Number: 3006425876-2021-00161
• Device Sequence Number: 11623862
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/08/2021

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?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.