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

Model Number	2271603-4J
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 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 17 jan 2025 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 after opening the package and attaching the track care 72 to the patient, a medical staff heard air leak sound, and upon checking, she found that the injection port was not attached from the beginning and was leaking gills.
Event or Problem Description
It was reported that after opening the package and attaching the track care 72 to the patient, a medical staff heard air leak sound, and upon checking, she found that the injection port was not attached from the beginning and was leaking gills.
Additional Manufacturer Narrative
H6: 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 17 jan 2025 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 (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 " after opening the package and attaching the track care 72 to the patient, a medical staff heard air leak sound, and upon checking, she found that the injection port was not attached from the beginning and was leaking gills." regarding part 2271603-4j was confirmed.The root cause was determined.A risk assessment was performed, and the ultimate risk was determined to be medium which does not require escalation to the capa review board as it has been already escalated in etq system.There have been no other complaints 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.The photo/video submitted in the email (issue background files section) depicts the reported issue.The complaint is confirmed the failure mode reported is a known failure mode already investigated and documented in etq system under qnc-mag-21-00337.During process investigation of reported failure mode, the following root causes were identified.Potential root cause 1: raw material could be mixed into container of material ready for next process during filling of raw material container.Potential root cause 2: the catheter without irrigation could be mixed with the acceptable product during this rework process.The following options were implemented to avoid recurrence: action 1: evaluate and modify the work area in the flapper irrigation assembly process of assembly line #3.To eliminate the risk of mixed material without flapper into acceptable product container.Action 2: implement the necessary controls to avoid performing any rework procedure at the final inspection station, at assembly line #3.

• 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): AVANOS MEDICAL INC; 5405 windward parkway; alpharetta GA 30004
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21182508
• Report Number: 8030647-2025-00010
• Device Sequence Number: 18274643
• Product Code: BSY
• UDI-Device Identifier: 00609038994260
• UDI-Public: (01)00609038994260
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 2271603-4J
• Device Catalogue Number: 2271603-4J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 06/24/2025
• 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