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

Model Number	IPN046435
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient, there was a separation between the gray securement piece and the flexible silicone piece inside, so the ez-blocker was not properly secured to the multiport adapter.As a result, the device was dislodged mid-case.The issue was resolved by isolating the lung again and repositioning the ez-blocker.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that while in use on a patient, there was a separation between the gray securement piece and the flexible silicone piece inside, so the ez-blocker was not properly secured to the multiport adapter.As a result, the device was dislodged mid-case.The issue was resolved by isolating the lung again and repositioning the ez-blocker.No patient harm or injury.The patient status is 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.The customer has reported the separation of the gray securement piece and the flexible silicone piece inside.The manufacturing site reports "these 2 pieces are not fixed together per specification of product.These 2 parts are inserted on the catheter but not glued together.Missing cap or silicone gasket, their wrong position/orientation or damaging would be detected during manufacturing and qc inspections and the product would be scrapped." it was also reported that "the review of dhr revealed no production issues from the perspective of the reported defect and the time of manufacture of the complained lot." the instructions for use (ifu) for this product mentions the complete procedure for manipulation of the product including the fixation of the catheter through the cap with the silicone gasket.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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: EZ-BLOCKER KIT
• Common Device Name: EZ BLOCKER
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16825878
• Report Number: 3006425876-2023-00479
• Device Sequence Number: 17890064
• Product Code: CBI
• UDI-Device Identifier: 14026704589958
• UDI-Public: 14026704589958
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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 Model Number: IPN046435
• Device Catalogue Number: MG-02770-002
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown