MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL 2.5MM LIFEPORT ADAPTER; 2.5MM LPA

Catalog Number 9025

Device Problem Disconnection (1171)

Patient Problem Bacterial Infection (1735)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

User facility report mw5150407 received from fda on 02/01/2024.At this time, the user facility had not contacted bunnell to report a complaint or request return authorization for the product.Bunnell clinical representative contacted the user facility to attempt to receive additional information.Based on this conversation with the user facility, it did not appear the bunnell lifeport itself resulted in the reported incident.The user facility was requested to contact bunnell's hotline if additional issues recurred.The user facility had already disposed of the suspect device.Therefore, no investigation of the device was possible.Retain samples for the reported lot number (23043166) were evaluated, with no physical abnormalities noted.Therefore, connection to the et tube should be as normally observed.Complaint records were evaluated.There have been zero reports of any other issues, of any kind, associated with lot number 23043166.Additionally, when 3 years of investigation records were reviewed, there have been no other reports of lifeport adapters disconnecting from the et tube.

Event Description

As reported in user facility report mw5150407: "patient on a high frequency jet ventilator with endotracheal tube adapter continuously popping off from site causing opening of system.Patient required reintubation and new tubing system.Patient now positive for klebsiella oxytoca, collected from endotracheal aspiration." the user facility did not contact bunnell to initiate an investigation or return the suspect device.Bunnell clinical representative contacted user facility for additional information.The user facility was requested to call bunnell's hotline if this is a reoccurring issue and keep packaging to track any lot numbers involved.Bunnell's clinical representative was told the user facility has not had other issues.

• Brand Name: BUNNELL 2.5MM LIFEPORT ADAPTER
• Type of Device: 2.5MM LPA
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer (Section G): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer Contact: curtis olsen ; 436 lawndale drive; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 18703718
• MDR Text Key: 335364697
• Report Number: 1719232-2024-00001
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9025
• Device Lot Number: 23043166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other