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

Catalog Number	HUD00540
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024, it was discovered that the bottle was "not punctured despite being properly screwed in" causing the patient on an aerosol mask to desaturate.The customer reported the patient was "not receiving the correct amount of oxygen needed".The customer did not report any serious injury, medical intervention, or follow-up care as a result of the reported event.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, 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 customer, on (b)(6) 2024, it was discovered that the bottle was "not punctured despite being properly screwed in" causing the patient on an aerosol mask to desaturate.

• Common Device Name: KIT,HUMID,AQUAPAK,540ML,H2O, ADPT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20762749
• Report Number: 1417592-2024-00986
• Device Sequence Number: 8393369
• Product Code: BTT
• UDI-Device Identifier: 20197344007155
• UDI-Public: 20197344007155
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: HUD00540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/22/2024
• 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 Sex: Unknown