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

Model Number	35216
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
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 in-progress.All information reasonably known as of 08-jan-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).
Event or Problem Description
It was reported, the clinician noticed an air leakage from the endotracheal tube of a patient on a mechanical ventilator.The endotracheal tube cuff, pilot balloon, did not deflate with manipulation; thus the doctor decided to change the endotracheal tube.The procedure was uneventful.No additional was provided.
Event or Problem Description
Additional information received 14-jan-2019 stating, the patient was intubated (b)(6) 2018 at 4pm and the device was in place until the incident on (b)(6) 2018 at 11 am.The procedure was uneventful.
Additional Manufacturer Narrative
All information reasonably known as of 18-jan-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.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(6) 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.
Additional Manufacturer Narrative
The device history record for the reported lot number, um6154xxx, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One used sample was received and no product packaging was received.The product did not contain a lot number identification.The device was evaluated and the failure was confirmed.The investigation concluded the product failure appeared to be potentially due to inadequate solvent bonding; however, a definitive root cause could not be determined.All information reasonably known as of 15-apr-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.

• Brand Name: HALYARD MICROCUFF ENDOTRACHEAL TUBE - ADULT-10.8-8.0-28
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8233324
• Report Number: 3011270181-2019-00001
• Device Sequence Number: 1621414
• Product Code: BTR
• UDI-Device Identifier: 30680651352164
• UDI-Public: 30680651352164
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K113333
• 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,Followup
• Report Date (Section B): 03/21/2019

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 Expiration Date: 06/30/2021
• Device Model Number: 35216
• Device Catalogue Number: 991035216
• Device Lot Number: UM6154XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/14/2019; 02/05/2019; 03/21/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/21/2019; 02/18/2019; 04/16/2019
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 65