MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEM; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	195-4J
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in progress.All information reasonably known as of 14 nov 2024 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 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.
Event or Problem Description
It was reported, the on-site nurse successfully suctioned [the patient] several times during intubation; however, when aspiration was performed, suction did not occur.The nurse noted there was a white foreign substance in the catheter when the tip (marker part) of the catheter was cut, the contents were taken out.The nurse additionally reported, it may be a foreign body that was originally in the patient's body, or it may be some part of another product.The device was replaced; there was no reported injury.
Additional Manufacturer Narrative
Additional information: d4.Correction: d4.The actual sample from the reported event was returned and processed for evaluation.All information reasonably known as of 31 jan 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 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 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.
Additional Manufacturer Narrative
Correction: g1 additional information: d4.The sample from the reported event was returned and processed for evaluation.Per the sample evaluation results, the event was confirmed.The root cause was traced to the manufacturing process.Processes have been implemented to prevent the reoccurrence of the reported issue.Device history records were reviewed and there were no abnormal processing issues noted.All products/packaging were produced per the approved manufacturing procedures, specifications, and inspections and released.All information reasonably known as of 29 may 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 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 complaint database and identified as avanos legacy complaint: (b)(4)_ air life (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.
Event or Problem Description
It was reported, the on-site nurse successfully suctioned [the patient] several times during intubation; however, when aspiration was performed, suction did not occur.The nurse noted there was a white foreign substance in the catheter when the tip (marker part) of the catheter was cut, the contents were taken out.The nurse additionally reported, it may be a foreign body that was originally in the patient's body, or it may be some part of another product.The device was replaced; there was no reported injury.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM
• 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, mx 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 4704485487
• MDR Report Key: 20702904
• Report Number: 8030647-2024-00083
• Device Sequence Number: 20885795
• Product Code: BSY
• UDI-Device Identifier: 00609038993126
• UDI-Public: (01)00609038993126(10)30327256(11)240529
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

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: 195-4J
• Device Catalogue Number: 195-4J
• Device Lot Number: 30327256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 04/29/2025
• Initial Report FDA Received Date: 11/17/2024
• Supplement Report FDA Received Date: 01/31/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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