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

Model Number	35214
Medical Device Problem Codes	Material Rupture (1546); Gas/Air Leak (2946); Pressure Problem (3012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.All information reasonably known as of 05 jun 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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
Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the second of four reports.Refer to 3011270181-2020-00083 for the first report.Refer to 3011270181-2020-00085 for the third report.Refer to 3011270181-2020-00086 for the fourth report.It was reported that "several" incidents of subglottic et [endotracheal] tube cuff leaks occurred that are noticed via cuff pressure checks "anywhere from 2-14 days after intubation." anesthesiologist does not always check ett [endotracheal tube] cuff patency prior to intubation.All tubes are placed via video laryngoscope to confirm correct tube placement.When cuff leaks are noticed all patients have required reintubation without difficulty.Pilot balloon also ruptured.No patient injuries.Patient information was provided.Date intubated: (b)(6) 2020, date extubated: (b)(6) 2020, peep settings: 6-16, no lot code provided.Additional information received 22-may-2020 indicated the product was not altered in any way prior to use.The problem was discovered through normal patient monitoring.The incident did not occur during surgery, did not occur during transport, and the patient was not hand bagged.It is unknown if the tube migrated.No abnormalities were noted previous to intubation or re-intubation.It is unknown how much pressure was used to inflate the balloon and no patient comorbidity information was provided.
Event or Problem Description
Correction: date intubated: (b)(6) 2020, date extubated: (b)(6) 2020, peep settings: 8-16.
Additional Manufacturer Narrative
Corrected data: b5.All information reasonably known as of (b)(6) 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 ADULT ENDOTRACHEAL TUBE
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10126208
• Report Number: 3011270181-2020-00084
• Device Sequence Number: 17046824
• Product Code: BTR
• UDI-Device Identifier: 10609038352142
• UDI-Public: 10609038352142
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K113333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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 Model Number: 35214
• Device Catalogue Number: 103521401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/31/2020
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 112