MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF ENDOTRACHEAL TUBE - ADULT-10.8-8.0-28; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number 35216

Device Problem Gas/Air Leak (2946)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Fda user facility report # (b)(4) is for reference.A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.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.(b)(4).

Event Description

Fda medwatch / fda user facility report # (b)(4).Was received on 11-aug-2020, and the following information was provided: "at the beginning of shift, noted an audible cuff leak on pts [patient's] ett [endotracheal tube].Volumes mismatched on vent (i.E.In 500, out 300).Not desaturating.Called rt [respiratory therapist] to bedside.Air added to ett cuff and stopcock added to pilot balloon - has been working in cases w/ slow cuff leaks.Rts added about 20ccs to cuff w/ stopcock, still notable cuff leak.Micu [medical intensive care unit] team and fellow updated.Micu fellow came in and exchanged ett over a bougie.Charge rn [registered nurse] aware.Ett info #7 5 microcuff oronasal tube, no lot or id# on tube.Once the tube was out, re-tested cuff w/ air and it appeared intact.After ett exchange (meds included roe [rocephin], etomidate, propofol), patient did require an increase in levo [levophed] after dropping his blood pressure [this] was temporary and we were able to down-titrate levo afterwards.".

Manufacturer Narrative

All information reasonably known as of 23 sep 2020 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.

• Brand Name: MICROCUFF ENDOTRACHEAL TUBE - ADULT-10.8-8.0-28
• Type of Device: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10483482
• MDR Text Key: 206167513
• Report Number: 3011270181-2020-00115
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 00609038352169
• UDI-Public: 00609038352169
• Combination Product (y/n): N
• PMA/PMN Number: K113333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35216
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR