MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-5.0-3.5-12; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35112
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 13 aug 2021 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 complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical inc.Received a single report that referenced five different incidences, which were associated with separate units, involving five different patients.This is the second of five reports.Refer to 3011270181-2021-00038 for the first report.Refer to 3011270181-2021-00040 for the third report.Refer to 3011270181-2021-00041 for the fourth report.Refer to 3011270181-2021-00042 for the fifth report.It was reported that the blue connector came away from the microcuff et tube (ett).No report of patient 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 24 aug 2021 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 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-5.0-3.5-12
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12335633
• Report Number: 3011270181-2021-00039
• Device Sequence Number: 17415254
• Product Code: BTR
• UDI-Device Identifier: 00609038351124
• UDI-Public: 00609038351124
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 35112
• Device Catalogue Number: N/A
• Device Lot Number: CM9219001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1