MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 13222

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  malfunction  

Event Description

The doctor was intubating the patient with an 8.0 endo tracheal tube (ett) and the cuff blew when inflated with air.I am reporting this one specific device, but it is important to know the following: there have been 5 etts, all sizes unknown, that have blown when the cuff was inflated or have slowly leaked air which could lead to problems.Patients have required reintubation.It is concerning when this happens in a code blue when intubation is needed emergently.All of the devices have not been saved.The lot numbers involved: #aa9154v01, #aa968v01, #aa8072v01.At this point, there is no recall.Our hospital has file a claim with the vendor.Before replacement, they are waiting until the issue is deemed a true product recall.Please look into this.Manufacturer response for endotracheal tube, microcuff subglottic suctioning endotracheal tube (per site reporter).Do not know.Vendor is waiting to see if there is a true product recall.

• Brand Name: HALYARD
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 winward parkway; alpharetta GA 30004
• MDR Report Key: 9535215
• MDR Text Key: 173211604
• Report Number: 9535215
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2019,12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13222
• Device Catalogue Number: 13222-01
• Device Lot Number: AA9168V01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1