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

Model Number	35111
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Decreased Respiratory Rate (2485); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, in october, the patient was intubated with a cuffed ett, which was noted to have minimal occluding volume.A chest x-ray (cxr), for tube placement, read "the tube was deep".A respiratory therapist (rt) attempted to pull the tube back 1 cm and noted high pressures on the vent.Gurgling was heard during the rts attempt to bag the baby and the tube was being retaped (with noted difficulty); secretions could be heard during the suction attempt; however, the tube did not feed all the way in and only a "little secretion" was returned.The suction regulator was changed twice and suction was confirmed.Etco2 was confirmed and they attempted to inflate and deflate the cuff with no improvement.The rt put tension on the tube and pulled back to 6 cm and things appeared to improve; an x-ray was ordered.The baby became difficult to bag again and required very high pressures; the medical doctor (md) removed the tube; the baby was reintubated with ease and tube placement was verified with a cxr.Additional information received 14dec2023 reported, the ett was in place for approximately 4 hours.Additional information received 18dec2023 reported, a lot of force was used to get the suction past the cuff.
Additional Manufacturer Narrative
4581-appropriate clinical signs, symptoms, conditions term/code not available: the baby became difficult to bag.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 05 jan 2024 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 21 cfr 803, 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
Correction: e1.The actual sample from the reported event was returned for evaluation; however, only half of the reported endotracheal (ett) tube was returned along with a used closed suction catheter (csc).No obvious obstruction was noted during visual examination of the device; however, a smeared-like dried clear residue was seen.The returned sample was measured and was found to be within specification.Additionally, the sample was tested by inserting the csc into the ett; when the csc reached the end, the catheter tip became stuck in the end tip of the ett.The reported event could be confirmed as reported; however, the root cause is undetermined.All information reasonably known as of 05 mar 2024 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)(6).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 TUBE
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): COMMAND MEDICAL NICARAGUA SA; km 12.5 carretera norte; parque industrial las mercedes, edificio 16; managua, managua
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18459744
• Report Number: 3011270181-2024-00007
• Device Sequence Number: 17921459
• Product Code: BTR
• UDI-Device Identifier: 00609038351117
• UDI-Public: 00609038351117
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 35111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 19 DA
• Patient Sex: Female
• Patient Weight: 2 KG