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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint reported that: "we inflated the green balloon to isolate the right mainstem.During the case, right upper lobe begin to inflate.".
Event or Problem Description
The complaint was reported as: "we inflated the green balloon to isolate the right mainstem.During the case, right upper lobe begin to inflate.Additional air was injected.Then same issue occurred.Then after a while, total tidal volume on the vent began to decrease then pt's saturation began to decrease.The right (green) balloon was deflated and the position of the balloon was examined bronchoscopically, which was fine.This occurred at at least a couple of times.The anesthesiologist noticed that the left (blue) balloon kept inflating.So, what she did was to deflate the left balloon (blue) and inject 1 ml of air into the right (green).This solved the issue.On examination of the device after the case, i was able to inflate the blue balloon by compressing the green balloon.So my conclusion is that there was a tiny communication between the two channels." no patient injury or consequence reported.The patient condition was reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Additional information was received regarding the patient desaturation and the sales rep has reported "the lowest was 94%, but she was in the high 90s most of the case." 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 "15ml of the air was let in the balloon on yellow extrusion through yellow pilot valve and after few minutes the blue pilot valve and the balloon on blue extrusion and started slowly inflating." a device history record review was performed and no relevant findings were identified.The manufacturing site reports that the complaint was confirmed based on the functional inspection.The root cause is listed as supplier related.A capa was opened to address this issue.

• 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: 15527273
• Report Number: 3006425876-2022-00844
• Device Sequence Number: 11431550
• Product Code: CBI
• UDI-Device Identifier: 10801902142372
• UDI-Public: 10801902142372
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2023
• Device Model Number: IPN913391
• Device Catalogue Number: MG-02770-002
• Device Lot Number: 71F21J2659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 104 KG