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	Insufficient Information (4580)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, a trached patient required humidification via trach collar/bubble bottle.A new hudson aquapak bubble bottle was used during shift with many problems."the bubble bottle trouble shot by 3 rn's and rt with minimal effect.The bottle noted to not be properly humidifying ra which resulted in patient requiring additional saline nebs, suctions and possible trach change d/t thick secretions.When trouble shot the bottle would intermittently work properly but was unreliable".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 facility, a trached patient required humidification via trach collar/bubble bottle.A new hudson aquapak bubble bottle was used during shift with many problems.

• Common Device Name: KIT,HUMID,AQUAPAK,540ML,H2O, ADPT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20757111
• Report Number: 1417592-2024-00975
• Device Sequence Number: 12867447
• 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?: Yes
• 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