MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; KIT,HUMID,AQUAPAK, 540ML,H2O,W/ADPT

Catalog Number	HUD00540
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, a pediatric rapid response was initiated at 0430 due to increased oxygen needs and extreme lethargy in the patient being hospitalized for rsv and acute respiratory failure.The icu rn suggested trying a face mask to improve saturations.When rt arrived, it was noted that the o2 bubbler was not working properly (interruption of oxygen being delivered).A new bubbler was obtained and resulted in improvement in o2 status.The oxygen bubbler was found to not be punctured, although pieces of plastic were broken off appropriately and oxygen had been connected appropriately.Patient has been since discharged home.No additional information at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, on (b)(6) 2026, a pediatric rapid response was initiated at 0430 due to increased oxygen needs and extreme lethargy in the patient being hospitalized for rsv and acute respiratory failure.The icu rn suggested trying a face mask to improve saturations.When rt arrived, it was noted that the o2 bubbler was not working properly (interruption of oxygen being delivered).A new bubbler was obtained and resulted in improvement in o2 status.The oxygen bubbler was found to not be punctured, although pieces of plastic were broken off appropriately and oxygen had been connected appropriately.

• Brand Name: MEDLINE
• Common Device Name: KIT,HUMID,AQUAPAK, 540ML,H2O,W/ADPT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24431736
• Report Number: 1417592-2026-00144
• Device Sequence Number: 16028283
• Product Code: BTT
• UDI-Device Identifier: 10197344007158
• UDI-Public: 10197344007158
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HUD00540
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 MO
• Patient Sex: Male
• Patient Weight: 8 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White