MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13220
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, aa7240v01, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 02-nov-2018 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 avanos medical, inc.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 avanos medical, inc.Avanos medical, inc.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 avanos medical, inc.Complaint the device was not returned.
Event or Problem Description
It was reported the microcuff burst during use.There was no reported patient injury.Additional information received 25-oct-2018 stated the device was leaking just after intubation.All the protocols were followed and precautions were taken while intubating the patient.Additional information has been requested.

• Brand Name: MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8052865
• Report Number: 9611594-2018-00203
• Device Sequence Number: 13904940
• Product Code: BTR
• UDI-Device Identifier: 30680651132209
• UDI-Public: 30680651132209
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2018

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: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: 13220
• Device Catalogue Number: 991013220
• Device Lot Number: AA7240V01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2018
• Initial Report FDA Received Date: 11/08/2018
• Patient Sequence Number: 1