MAUDE Adverse Event Report: HALYARD HEALTH ADULT 7.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is available for return but has not been received yet.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
Halyard received a single report that referenced two different incidences, which were associated with separate units.This is the first of two reports.Refer to 9611594-2017-00051 for the second report.It was reported that there is a 40% disconnect rate of the blue connector from the subglottic microcuff et tube.This concern is caused by stretching of the pvc ssm tube by the blue connector which causes a very loose fit.In some cases the fit is so loose that the connector simply falls out.Additional information was received the same day, 01-mar-2017 that states, the icu respiratory team leader describes the concern as follows: "we have had a number of microcuff tubes where the blue adaptor keeps coming out even after pushing it in to the hilt.I have one new tube in my office that i wanted to check myself.After pushing the blue tip all the way in, it causes the top part of the tube to expand, which becomes the real reason why the staff are seeing this more.My concern about this is when we are treating patients with high levels of oxygen and peep, this becomes a real problem when they are disconnected from the ventilator.¿ no additional information provided.

• Brand Name: ADULT 7.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6436196
• Report Number: 9611594-2017-00050
• Device Sequence Number: 511985
• Product Code: BTR
• UDI-Device Identifier: 30680651132209
• UDI-Public: 30680651132209
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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
• Operator of Device: Respiratory Therapist
• Device Model Number: 13220
• Device Catalogue Number: 991013220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/27/2017
• Patient Sequence Number: 1