MAUDE Adverse Event Report: AVANOS MEDICAL INC. MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL; VAP MICROCUFF ENDOTRACHEAL TUBES

Model Number	13222
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Extubate (2402)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 21-jan-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.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 four different events.This is the fourth of four reports.Refer to 9611594-2020-00010 for the first event.Refer to 9611594-2020-00011 for the second event.Refer to 9611594-2020-00012 for the third event.It was reported that the during use the endotracheal loss tidal volume while the patient was requiring mechanical ventilation.The patient had to undergo reintubation.The devise was tested for integrity prior to patient use.Additional information received 07-jan-2020 noted an fda medwatch/ fda user facility report # (b)(4) was received.
Additional Manufacturer Narrative
One sample device was received without the original packaging.A syringe was attached into the inflation balloon.The device appeared used with biological matter inside the tube.The device was evaluated, and the failure was confirmed.The root cause was not identified.All information reasonably known as of 13-may-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 product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 28-feb-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 SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 8.0 MM, ORAL
• Common Device Name: VAP MICROCUFF ENDOTRACHEAL TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9612914
• Report Number: 9611594-2020-00013
• Device Sequence Number: 11432175
• Product Code: BTR
• UDI-Device Identifier: 10680651132229
• UDI-Public: 10680651132229
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K131254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2020

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 Model Number: 13222
• Device Catalogue Number: 101322200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 02/05/2020; 04/22/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/01/2020; 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1