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

Model Number	35114
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.All information reasonably known as of 17 feb 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).
Event or Problem Description
Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving different patients.This is the fourth of four reports.Refer to 3011270181-2020-00025 for the first report.Refer to 3011270181-2020-00026 for the second report.Refer to 3011270181-2020-00027 for the third report.It was reported that the customer is "finding there are bubbles/condensation/fluid build up around the cuff." no patient injury reported.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
Additional information provided for d4: expiration date and h4: device manufacturer date all information reasonably known as of 29 apr 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
The actual complaint product was not returned for evaluation.Process/system evaluation was conducted.Leak of the inflation system is inspected 100% during production.A sample from every lot of production is conditioned for 24 hours and then checked for leak of the inflation system.Root cause could not be determined.All information reasonably known as of 09 apr 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: 9726528
• Report Number: 3011270181-2020-00028
• Device Sequence Number: 19461206
• Product Code: BTR
• UDI-Device Identifier: 10680651351149
• UDI-Public: 10680651351149
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2020

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 Expiration Date: 02/13/2024
• Device Model Number: 35114
• Device Catalogue Number: 103511406
• Device Lot Number: CM9045002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/05/2020; 04/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/09/2020; 04/30/2020
• Patient Sequence Number: 1