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

Model Number	98311
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: the inline suction catheter was placed on the patient while attached to the ventilator.[the] patient indicated something wasn't normal with his breathing and it was noted that air was leaving out of the opening where flush/lavage tubing is normally attached.[the] patient [was] given [a] new inline suction [catheter]; there was no reported injury.
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 16 jul 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings 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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported: the inline suction catheter was placed on the patient while attached to the ventilator.[the] patient indicated something wasn't normal with his breathing and it was noted that air was leaving out of the opening where flush/lavage tubing is normally attached.[the] patient [was] given [a]new inline suction[catheter]; there was no reported injury.
Additional Manufacturer Narrative
Correction: (b)(4) was incorrectly referenced in the initial report submission for fda initial mw report mw 8030647-2025-00070_ (b)(4), is an unrelated complaint and was inadvertently referenced in relationship to the reported event documented in fda initial mw report mw 8030647-2025-00070.Please disregard any reference to (b)(4).The correct air life complaint id related to fda initial mw report mw 8030647-2025-00070 is (b)(4).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 17 jul 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings 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 an sun med holdings llc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
Correction: upon further review, (b)(4) fda mw 8030647-2025-00070 was determined to be a duplicate of (b)(4) fda mw report mw 8030647-2025-00063.No further reports will be submitted in regard to the reported event in (b)(4) fda mw 8030647-2025-00070; all follow-up reports concerning the reported event were submitted in (b)(4) fda mw report mw 8030647-2025-00063.All information reasonably known as of 15 jan 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings 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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported: the inline suction catheter was placed on the patient while attached to the ventilator.[the] patient indicated something wasn't normal with his breathing and it was noted that air was leaving out of the opening where flush/lavage tubing is normally attached.[the] patient [was] given [a]new inline suction[catheter]; there was no reported injury.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM FOR ADULTS
• 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): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, mx 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22527447
• Report Number: 8030647-2025-00070
• Device Sequence Number: 15803180
• Product Code: BSY
• UDI-Device Identifier: 00609038983110
• UDI-Public: (01)00609038983110(10)20125277
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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: 98311
• Device Catalogue Number: 22103-5
• Device Lot Number: 20125277
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 12/16/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 07/17/2025; 01/15/2026
• 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 Sex: Male