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

Model Number	35116
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, water was in the cuff, but no leakage; there was no reported medical intervention or injury to the patient.
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 04 dec 2023 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.
Additional Manufacturer Narrative
Manufacturing site updated, based upon review of the complaint record, a new initial report will be submitted under 3011270181-2024-00038; no further information concerning this reported event will be submitted.All information reasonably known as of 21 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)(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.

• Brand Name: MICROCUFF PEDIATRIC ENDOTRACHEAL, TUBE, ORAL/NASAL MAGILL
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18267165
• Report Number: 8030647-2023-00152
• Device Sequence Number: 12737671
• Product Code: BTR
• UDI-Device Identifier: 00609038351162
• UDI-Public: 00609038351162
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: Other
• Device Model Number: 35116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown