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

Catalog Number	HCS7001
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "low pressure".
Additional Manufacturer Narrative
The unit was reported to have low pressure.Medline quality received one unit and visually inspected the sample; it appeared to be in used condition, the casing was closed, and the power button appeared out of place and had to be pushed back in.The unit was plugged into a power source and turned on; when the unit was turned to maximum, the pressure was 250 mmhg, which does not meet product specifications, and when the sample was opened to check for internal damages and defects, it was observed that the piston was loose.The reported complaint was confirmed with the sample received, and the division will monitor the complaint during quarterly trending and notify the manufacturing site of the issue on a quarterly basis.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: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50900411
• Report Number: 1417592-2026-51270
• Device Sequence Number: 6001749
• Product Code: BTA
• UDI-Device Identifier: 10193489036381
• UDI-Public: 10193489036381
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/24/2026

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: 6462109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/16/2023
• 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: 08/09/2023
• Initial Report FDA Received Date: 09/25/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown