MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, ELBOW WITH CAPS; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	92431
Medical Device Problem Codes	Decrease in Suction (1146); Excess Flow or Over-Infusion (1311); Unintended Deflation (4061)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
4581-appropriate clinical signs, symptoms, conditions term/code not available: device difficult to remove.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.All information reasonably known as of 29 apr 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 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.H3 other text : device not returned.
Event or Problem Description
Avanos medical inc.Received a single report that referenced 10 different incidences, which were associated with separate units, involving the same patient.This is the fifth of ten reports.Refer to 8030647-2024-00026 for the first report; refer to 8030647-2024-00027 for the second report; refer to 8030647-2024-00028 for the third report ; refer to 8030647-2024-00029 for the fourth report; refer to 8030647-2024-00031 for the sixth report; refer to 8030647-2024-00032 for the seventh report; refer to 8030647-2024-00033 for the eighth report; refer to 8030647-2024-00034 for the ninth report; refer to 8030647-2024-00035 for the tenth report.The parent of the patient reported, the area around the inline suction catheter(s) were filling up with air and then completely deflated.The catheter(s) were not easily removed from the patient¿s trach and the patient was no able to be suctioned effectively.There was no reported injury to the patient.Additional information received on 10apr2024 reported, there was no harm to the patient.
Additional Manufacturer Narrative
All information reasonably known as of 17 dec 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 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: BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, ELBOW WITH CAPS
• 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: 19212487
• Report Number: 8030647-2024-00030
• Device Sequence Number: 6904323
• Product Code: BSY
• UDI-Device Identifier: 00609038924311
• UDI-Public: 00609038924311
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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: Lay User/Patient
• Device Model Number: 92431
• Device Catalogue Number: 20083
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 12/18/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 24 MO
• Patient Sex: Female
• Patient Weight: 10 KG