MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CANISTER,SUCTION,850 CC W/FLOAT LID

Catalog Number	HCS7850
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, a resident was in need of emergency suction.During the event, a total of three canisters were reportedly obtained and all three did not provide suction.The resident was sent to the er and admitted to the hospital.The facility stated the resident passed away but that the cause of death was not because of the canisters.The facility stated the resident was sick already and that "he would have been more comfortable with the suctioning but we were unable to and had to call the squad because of the suctioning was not working and he was unable to take breathes because the airway needed suctioned".A definitive cause of death has not been provided to the manufacturer.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.Patient weight was not given.But 0kg was entered since the portal is not accepting the submission with the weight field blank.
Event or Problem Description
According to the facility, a resident was in need of emergency suction.During the event, a total of three canisters were reportedly obtained and all three did not provide suction.The resident was sent to the er and admitted to the hospital.The facility stated the resident passed away but that the cause of death was not because of the canisters.

• Brand Name: MEDLINE
• Common Device Name: CANISTER,SUCTION,850 CC W/FLOAT LID
• 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: 24082687
• Report Number: 1417592-2026-00046
• Device Sequence Number: 9665880
• Product Code: KDQ
• UDI-Device Identifier: 10884389144565
• UDI-Public: 10884389144565
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/15/2026

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?: No
• Device Catalogue Number: HCS7850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male