MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS, BALLARD ORAL CARE; BALLARD ORAL CARE Q4 KIT

Model Number	97021
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
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 05 mar 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.
Event or Problem Description
While the critical care nurse was performing oral care on the patient the suction swab fell apart in the patient's mouth and the nurse had to physically remove the sponge and green tip from the patient's mouth.There was no patient injury; the oral care device was replaced.
Additional Manufacturer Narrative
Correction: g1.Additional information-investigation conclusion: d4; h4; h6.The product involved in the report was not returned for evaluation, additionally, no visual evidence, such as photographs or videos were provided; therefore, a root cause could not be determined.The device history record for lot 1562633 was reviewed and the product was produced according to product specifications.As part of the quality control for the batch reported in the customer complaint (1562633), 315 units were selected as a representative sample from a total of (b)(4) units.No anomalies were detected during the quality control inspection.During the manufacturing of the subassembly (suction swab) used for packaging part number 97021 (batch 1562633), a sample of 125 units was taken from a total of (b)(4).The inspection was conducted to check for "missing or unconnected parts" and "damage or burns on the sponge." no defects were detected.Additionally, 20 force tests were performed on the sponge, with satisfactory results.All information reasonably known as of 01 aug 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.
Event or Problem Description
While the critical care nurse was performing oral care on the patient the suction swab fell apart in the patient's mouth and the nurse had to physically remove the sponge and green tip from the patient's mouth.There was no patient injury; the oral care device was replaced.

• Brand Name: AVANOS, BALLARD ORAL CARE
• Common Device Name: BALLARD ORAL CARE Q4 KIT
• 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, 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 21531683
• Report Number: 8030647-2025-00021
• Device Sequence Number: 20767319
• Product Code: NSB
• UDI-Device Identifier: 00609038970219
• UDI-Public: (01)00609038970219(10)1562633(17)260331(240)120002670(11)241212
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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 Expiration Date: 03/31/2026
• Device Model Number: 97021
• Device Catalogue Number: 97021
• Device Lot Number: 1562633
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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