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	Gas/Air Leak (2946)
Health Effect - Clinical Code	Hypoxia (1918)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 24-apr-2019 has been included in this health authority report.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.(b)(4).
Event or Problem Description
A medwatch report, (b)(4), was received received on 02-apr-2019, and the following information was provided: a patient in the icu developed a severe subglottic tube cuff leak on the overnight shift resulting in the need to replace the endotracheal tube with significant difficulty.The subglottic endotracheal tube had been in place for several days prior to the event.The clinical team attempted to resolve the issue by re-inflating the balloon and occluding the port used to fill the balloon in case it was leaking.Neither of these interventions was successful and the clinical team feels the tracheal balloon had failed during routine use.The endotracheal tube was ultimately replaced but lead to significant hypoxia that resolved once the tube was replaced.The patient has subsequently had a formal tracheostomy due to prolonged respiratory failure." no sample available-sw.
Additional Manufacturer Narrative
All information reasonably known as of 07-may-2019 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 database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
Event or Problem Description
A medwatch report, mw (b)(4), was received on 01-apr-2019, and the following information was provided: a patient in the icu developed a severe subglottic tube cuff leak on the overnight shift resulting in the need to replace the endotracheal tube with significant difficulty.The subglottic endotracheal tube had been in place for several days prior to the event.The clinical team attempted to resolve the issue by re-inflating the balloon and occluding the port used to fill the balloon in case it was leaking.Neither of these interventions was successful and the clinical team feels the tracheal balloon had failed during routine use.The endotracheal tube was ultimately replaced but lead to significant hypoxia that resolved once the tube was replaced.The patient has subsequently had a formal tracheostomy due to prolonged respiratory failure.

• 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: 8547236
• Report Number: 9611594-2019-00084
• Device Sequence Number: 13543163
• Product Code: BTR
• UDI-Device Identifier: 30680651132209
• UDI-Public: 30680651132209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 13220
• Device Catalogue Number: 991013220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 83 YR