MAUDE Adverse Event Report: Avanos Medical Inc Ballard Closed Suction System; BALLARD Closed Suction Catheter, Double Swivel Elbow

Model Number	99426
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation a review of the device history record is in-progress.All information reasonably known as of (b)(6) 2026 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 airlife represents all of the information known 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 airlife.Airlife has no independent knowledge of the event reported, but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as (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 a airlife product was defective or caused serious injury.
Event or Problem Description
It was reported that on the third day of use of the trachecare 72, hospital staff observed that the flapper valve had detached from the catheter mount side.The detached flapper valve was not found inside the tracheal tube, and no adverse health effects occurred.An additional flapper valve was found at the bedside and was presumed to have also detached.

• Brand Name: Ballard Closed Suction System
• Common Device Name: BALLARD Closed Suction Catheter, Double Swivel Elbow
• Manufacturer (Section D): Avanos Medical Inc; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): Westmed de Mexico, S.A. de C.V.; carretera internacional; salida norte no. 1053; magdalena, sonora 84160 ; MX 84160
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 50211821
• Report Number: 8030647-2026-00059
• Device Sequence Number: 6122733
• Product Code: BSY
• UDI-Device Identifier: 00609038994260
• UDI-Public: (01)00609038994260(10)30327334(11)240603(17)290602
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 99426
• Device Catalogue Number: 2271603-4J
• Device Lot Number: 30327334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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 Sex: Unknown