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

Model Number	35111
Medical Device Problem Codes	Gas/Air Leak (2946); Pressure Problem (3012)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 03 mar 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
It was reported that "air leaked from the tube during use.A doctor noticed an unnatural feeling of the tube on the day that the tube was placed in the patient, but it was used for a couple of days watching its states or changes.Ventilator¿s alarm did not ring.The tube was replaced for new one 3 days later.When the doctor checked the tube, there was an air leak around from the root of the inflating tube.The patient¿s hospitalization in icu was extended, but the patient¿s condition did not become severe." patient was moved to a ward facility.Additional information received 19-feb-2020 indicated that "because of bronchitis, the patient started to undergo artificial respiration since 24-jan-2020.An endotracheal tube was extubated and the new one was intubated on 30-jan-2020.Though the same size tube was placed in the patient, there was an obvious leak right after intubating.Firstly, leakage from the cuff was suspected, so the cuff pressure was adjusted.But the pressure did not decrease.It seemed there was no leak from the cuff.Secondly, the artificial ventilator was suspected for the leakage, but the leakage contributed even after changing the ventilator.On 06-feb-2020, the endotracheal tube was replaced for new one.The leakage from the tube was found when the user checked the tube that was removed from the patient.After replacing, no leakage was found.".
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The investigation remains in progress.All information reasonably known as of 27 mar 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.
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was returned for evaluation and the complaint was confirmed.No definitive root cause was established; however, a potential root cause was identified and actions have been implemented.All information reasonably known as of 12 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
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9782428
• Report Number: 3011270181-2020-00042
• Device Sequence Number: 688403
• Product Code: BTR
• UDI-Device Identifier: 10680651351118
• UDI-Public: 10680651351118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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?: No
• 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: 03/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 07/28/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/30/2020; 08/13/2020
• Patient Sequence Number: 1