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

Catalog Number	HCS7001
Medical Device Problem Codes	Decrease in Suction (1146); Mechanical Problem (1384); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when we arrived at the client's home to set it up for them and turned it on, we quickly noticed it wasn't sucking at all and then noticed the gage was not rising either.I've detached and reattached all tubes in hopes that would make a difference but even with no tube connections it should still have suction.".
Additional Manufacturer Narrative
The account reported finding "no suction"; the customer stated that after the unit was turned on, "it wasn't sucking at all" and "the gage was not rising either." medline quality received one unit for investigation, visually inspected the sample and it appeared to be in fair condition; the sample powered on, and when the unit was turned to maximum, the pressure was 100 mmhg, which does not meet product specifications.The reported problem was confirmed, and when the sample was opened to check for internal damages and defects, it was observed that there is a loose piston.Based on the sample and complaint details the root cause is considered to be a vendor product issue relating to the manufacturing process; the quality team will monitor this issue for trending purposes, the complaint has been provided to the vendor for further evaluation, manufacture/vendor investigation has been received, and reportability has not changed.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: ASPIRATOR,SUCTION,W/850CC CANISTER
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kurian jokutty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50850007
• Report Number: 1417592-2026-47229
• Device Sequence Number: 9553720
• Product Code: BTA
• UDI-Device Identifier: 10193489036381
• UDI-Public: 10193489036381
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K203135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: HCS7001
• Device Lot Number: 6462406
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown