MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION, NEONATE/PEDIATRIC, 8 FR, Y-ADAPT; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	198
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6/health effect - clinical code: ventilator alarming.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 17-may-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, 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.Device not returned.
Event or Problem Description
It was reported via fda user facility report mw report 0533050000-2023-8004.The following information: patient was having his diaper changed with 2 rns.All of the sudden, heard air leaking and then vent alarming.Upon inspection, end of endotracheal tube (ett) where it connects to the ballard suction actually broke off, rns pushed staff assist, team at bedside instructed to pull ett [endotracheal tube] and bag, team reintubating patient.Suction adapter that inserts into et tube broke off after a patient move.The tip of the adapter was wedged inside of the et tube which did not allow for any manual or mechanical ventilation connectivity.Decision was made to pull et tube and reintubate.No patient harm after reintubation.Additional information received 28-apr-2023 stating it was unknow how long the closed suction catheter (csc) was in place prior to the reported incident occurring.The product was not altered in anyway prior to the reported incident occurring.

• Brand Name: BALLARD CLOSED SUCTION, NEONATE/PEDIATRIC, 8 FR, Y-ADAPT
• 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 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16976463
• Report Number: 8030647-2023-00080
• Device Sequence Number: 2317500
• Product Code: BSY
• UDI-Device Identifier: 00609038938264
• UDI-Public: 00609038938264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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: 198
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 04/26/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 2 YR
• Patient Sex: Male