MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRANSPORT CIRCUIT W/ BV - LF

Catalog Number DYNJAA300

Device Problems Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the patient was disconnected from the main ventilator and was connected to the transport vent via the transport circuit.Per report, after an unidentified amount of time, shortly after connecting the transport circuit to the patient's endotracheal tube, no visual patient chest rise was noted.The patient was reportedly immediately connected back to the main ventilator.Reportedly, the transport circuit's beak valve was stuck in the closed position resulting in inability to ventilate the patient.It was added that the product was visually inspected prior to use and no issue was identified at that time.The transport circuit was reportedly not expired.There was no serious injury reported related to the event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the beak valve of the transport circuit was stuck in closed position.

Manufacturer Narrative

Samples were returned for evaluation.Visual and functional testing was done and the complaint could not be confirmed with the returned samples.All one way valves in the circuits opened up freely and all peep valves were adjustable without difficulty.A root cause could not be determined at this time.If additional information becomes available, a supplemental medwatch will be filed.

• Type of Device: TRANSPORT CIRCUIT W/ BV - LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8204493
• MDR Text Key: 131742727
• Report Number: 1417592-2018-00135
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJAA300
• Device Lot Number: 18PB9252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention