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

Catalog Number	HCS7001
Medical Device Problem Codes	Infusion or Flow Problem (2964); Suction Failure (4039)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the device stopped working on (b)(6) 2025.The customer said that the aspirator would not "accelerate past zero" and that her son is at risk for aspiration of fluids due to brain injury.The customer reported her son was admitted to the icu and put on a ventilator on (b)(6) 2025 but is now "off the vent" and doing breathing trials with supplemental oxygen.
Additional Manufacturer Narrative
According to the customer, the device stopped working on (b)(6) 2025.The customer said that the aspirator would not "accelerate past zero" and that her son is at risk for aspiration of fluids due to brain injury.The customer reported her son was admitted to the icu and put on a ventilator on (b)(6) 2025 but is now "off the vent" and doing breathing trials with supplemental oxygen.No additional information is available at this time.It has been determined that the reported event caused or contributed to (death/serious injury), therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Update to d4: lot #.Update to h6: investigation findings (c).

• Common Device Name: ASPIRATOR,SUCTION,W/850CC CANISTER
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22849558
• Report Number: 1417592-2025-00399
• Device Sequence Number: 4488465
• Product Code: BTA
• UDI-Device Identifier: 10193489036381
• UDI-Public: 10193489036381
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 09/10/2025

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: Lay User/Patient
• Device Catalogue Number: HCS7001
• Device Lot Number: 6462303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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