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

Model Number	13220
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
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 returned 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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
Halyard received a single report that referenced two different incidences, which were associated with separate units.This is the second of two reports.Refer to 9611594-2017-00050 for the first report.It was reported that, the second issue is the stuck ssm blue connector either in the resuscitation bag adapter or trach care swivel adapter.The connections become so tight that it takes a wedge or kelley forceps to separate the blue connector from resuscitation bag or trach care swivel.This is extremely concerning because the patient can't be returned to the ventilator after resuscitation and or the trach care cannot be changed expediently until the connector is removed with a tool that is often not readily available.There were no patients injured as a result of the reported connector disconnections and/or stuck connector.

• Brand Name: ADULT 7.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING
• Common Device Name: VAP MICROCUFF ENDOTRACHAEL TUBS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6437826
• Report Number: 9611594-2017-00051
• Device Sequence Number: 565774
• 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