MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-4.3-3.0-10; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35111
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Extubate (2402); Low Oxygen Saturation (2477)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 13-dec-2019 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).
Event or Problem Description
It was reported the endotracheal tube (ett) had a "possible hole or crack that was not noticed upon insertion." there was no reported patient injury.Additional information received 26-nov-2019 stated the patient was intubated due to work of breathing (wob) and sustained desaturations.About 2-hours after the patient was intubated the respiratory therapist (rt) was bag/saline suctioning the patient and noticed bubbles coming from underneath the tape around the ett.Saline was coming out of the port and bubbles were coming up through the cloth tape.The patient experienced loss of volumes on the ventilator and the patient's saturations were not within the desired range.The patient required reintubation with another ett.
Additional Manufacturer Narrative
One used microcuff endotracheal ( et) tube was returned.No product packaging was received with the sample device.The device was evaluated.The et tube was received with the vent connector detached and missing.The vent connector was not received with the sample.No damage or defects were noted to the cuff, inflation line, pilot balloon, or tube.A definitive root cause was not identified; however a potential root cause was identified and actions have been implemented.All information reasonably known as of 13-aug-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 PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-4.3-3.0-10
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9474840
• Report Number: 3011270181-2019-00075
• Device Sequence Number: 11440181
• Product Code: BTR
• UDI-Device Identifier: 10680651351118
• UDI-Public: 10680651351118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 35111
• Device Catalogue Number: 103511101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 WK
• Patient Weight: 4