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

Model Number IPN913391

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Event 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.

Event 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.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for 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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: EZ-BLOCKER KIT
• Type of Device: 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: 17494253
• MDR Text Key: 320859380
• Report Number: 3006425876-2023-00832
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K121462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.