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	05/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the "humidification bottle was not adequately punctured and patient with tracheostomy did not receive humidification" causing the patient "to have thick secretions and frequent sustained desaturations".The customer reported that the patient required "additional neb treatments, briefly required increased oxygen requirements, and additional cpt (cupping and cough assist)" due to the reported issue.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, 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 customer, on (b)(6) 2024 the "humidification bottle was not adequately punctured and patient with tracheostomy did not receive humidification" causing the patient "to have thick secretions and frequent sustained desaturations".

• 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: 20758592
• Report Number: 1417592-2024-00980
• Device Sequence Number: 15593830
• 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
• 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: 10/30/2024
• 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 Age: 14 YR
• Patient Sex: Female
• Patient Weight: 12 KG