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

Model Number	13220
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not available for this report.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 11jul2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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
It was reported that the endotracheal tube adapter disconnects too easily, resulting in a disconnection of the patient from the ventilator.This happens frequently after using an ambu bag on the adapter.Per additional information was received on 29-jun-2017, there was no patient injury and no medical intervention.No additional information was provided at this time.

• Brand Name: ADULT 7.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING
• Common Device Name: VAP ENDOTRACHEAL TUBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6728758
• Report Number: 9611594-2017-00106
• Device Sequence Number: 932084
• Product Code: BTR
• UDI-Device Identifier: 30680651132209
• UDI-Public: 30680651132209
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2017

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: Other Health Care Professional
• Device Model Number: 13220
• Device Catalogue Number: 991013220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/20/2017
• Patient Sequence Number: 1