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

Model Number	35115
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hypoxia (1918)
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 29 jul 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that "invasively ventilated pt [patient] was noticed to be desaturating (paediatric) and increasing etco2 post intubation in ed [emergency department] (approximately 4 hours post-intubation).Tube was checked for patency and, via suction catheter, noted hard to get access.Tube was removed, kink noted and patient re-tubed." no patient injury was reported; however, medical intervention was performed.Patient re-tubed prior to being flown to another hospital.Additional information received 11-jul-2019 indicated that the "intubation was a straight forward grade 1 intubation without any complications.I used a mac 2 blade on the cmac in ed.I did not use a bougie or stylet at any time during the intubation.The ett [endotracheal tube] was secured using a tube tie and position confirmed with capnography.Tube was 15cm at the lips after being secured.No issues ventilating the child after the initial intubation.".
Additional Manufacturer Narrative
One used sample with product packaging was received.The device was evaluated, the failure was not confirmed.A root cause could not be determined.The device history record for the reported lot number, um5183xxx, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 24-sep-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 halyard health 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
Lot number added to section d4.The investigation is in progress.All information reasonably known as of 01 aug 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 halyard health complaint database and identified as complaint comp-(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: 8837913
• Report Number: 3011270181-2019-00029
• Device Sequence Number: 2587410
• Product Code: BTR
• UDI-Device Identifier: 10680651351156
• UDI-Public: 10680651351156
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2019

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 Model Number: 35115
• Device Catalogue Number: 991035115
• Device Lot Number: UM5183XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 10/01/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/02/2019; 10/25/2019
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 20