MAUDE Adverse Event Report: AVANOS MEDICAL INC BALLARD* CLOSED SUCTION SYSTEM; TURBO-CLEANING CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW - ADULT

Model Number	99430
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flapper valve stays open during use.(it does not close) the patient uses it without any problem until the preparation before wearing it and for about 24 hours.
Additional Manufacturer Narrative
H6: 3038: catheter.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 10 dec 2024 has been included in the 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 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 airlife.Airlife 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 airlife complaint database and is 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 a airlife product is defective or causes serious injury.
Event or Problem Description
It was reported that the flapper valve stays open during use.(it does not close) the patient uses it without any problem until the preparation before wearing it and for about 24 hours.
Additional Manufacturer Narrative
H6: 3038: catheter.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 10 dec 2024 has been included in the 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 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 airlife.Airlife 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 airlife complaint database and is 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 a airlife product is defective or causes serious injury.The complaint of "flapper valve stays open during use." regarding part 22716-4j was confirmed through sample evaluation results.The root cause was determined to be a result of inadequate assembly of the wedge plug which keeps the flapper valve in the closed position after assembly and the subsequent sterilization process until reaches the end user.The steps for the manual operation of the assembly of the wedge plug were not correctly performed by the operator due to lack of attention to detail and not following the steps described in the job aid.The personnel at operations and quality have been informed of this failure mode in order to avoid reoccurrence.A risk assessment was performed, and the ultimate risk was determined to be low which does not require the initiation of a capa.There has been one other complaint regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

• Common Device Name: TURBO-CLEANING CLOSED SUCTION CATHETER, DOUBLE SWIVEL ELBOW - ADULT
• 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, mexico 84160 ; MX 84160
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20897867
• Report Number: 8030647-2024-00090
• Device Sequence Number: 15704773
• Product Code: BSY
• UDI-Device Identifier: 00609038994307
• UDI-Public: (01)00609038994307(10)20125265
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 99430
• Device Catalogue Number: 22716-4J
• Device Lot Number: 20125265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/12/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown