MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL-4.3-3.0-10; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	35111
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): no code available: reintubated.A review of the device history record is not possible as no lot number was provided.The sample is reported to be available, but has not yet been received by the manufacturer.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 "blood adhered to the distal end of the tube and the tube was occluded.Intubating a patient was needed again." no patient injury reported.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
Additional information: b5, b7, d10.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 15 jan 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 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
Additional information received 25-dec-2020 indicated the device was used by oral intubation.The tube was clogged and the patient had to be extubated and re-intubated by using a new device of the same model.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The sample was received without the original packaging; no lot number information was retrieved.There was no visible build-up inside the et tube or vent connector.The vent connector appeared to have openings.The balloon cuff and pilot balloon did not appear clogged or blocked.The reported event could not be confirmed.No root cause could be identified.All information reasonably known as of 24 mar 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 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-4.3-3.0-10
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11056695
• Report Number: 3011270181-2020-00135
• Device Sequence Number: 14116319
• Product Code: BTR
• UDI-Device Identifier: 10680651351118
• UDI-Public: 10680651351118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2021

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: 35111
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/25/2020; 03/04/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/15/2021; 03/27/2021
• Patient Sequence Number: 1