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

Model Number	IPN046435
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaints reports that: "the balloon inflates but leaks out rather quickly".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).The actual sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports that a visual exam was performed and no defects were observed.It was also reported that functional testing was performed and the yellow balloon was inflated with air.The blue balloon did not inflate.After a few minutes the blue balloon remained empty and the volume of the yellow balloon did not change.The test was repeated, this time by inflating the blue balloon.After a few minutes the blue balloon remained the same and the yellow balloon was still empty.The device was then sent to the supplier for further evaluation.It was identified that there was a small cross-leak between balloons.A device history record review was performed and no relevant findings were identified.The manufacturing site reports that the complaint was confirmed.The root cause is listed as supplier related.A non-conformance was opened to address this issue.
Event or Problem Description
The complaints reports that: "the balloon inflates but leaks out rather quickly".No patient injury/consequence or medical intervention reported.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15224020
• Report Number: 3006425876-2022-00723
• Device Sequence Number: 6014243
• Product Code: CBI
• UDI-Device Identifier: 14026704589958
• UDI-Public: 14026704589958
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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
• Device Expiration Date: 10/02/2023
• Device Model Number: IPN046435
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 71F21K0512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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