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

Model Number	IPN913391
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "leakage during use.During the procedure, the balloons seemed to deflate slowly.As a result, the lung gradually came up during the operation.A tube that is at least 0.5 size larger is always used." no patient harm or injury.The patient status is reported as "fine".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "leakage during use.During the procedure, the balloons seemed to deflate slowly.As a result, the lung gradually came up during the operation.A tube that is at least 0.5 size larger is always used." no patient harm or injury.The patient status is reported as "fine".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4) complaint verification testing could not be performed as the sample is pending to be returned for analysis.A device history record review was performed and revealed no production issues from the perspective of the reported defect and the time of manufacture of the complained lot.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: EZ-BLOCKER KIT
• Common Device Name: EZ BLOCKER
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17494260
• Report Number: 3006425876-2023-00791
• Device Sequence Number: 17955293
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: Health Professional
• Device Expiration Date: 04/16/2025
• Device Model Number: IPN913391
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 71F23D1401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• 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.
• Patient Sex: Unknown