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); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr summary report covers malfunction events that occurred in q4 of 2024.The report summarizes 3 malfunction events involving aspirators & air com (hcs7001).Customer reported that ¿low pressure.¿.
Additional Manufacturer Narrative
This vmsr summary report covers malfunction events that occurred in q4 of 2024.Associated serial numbers: (b)(6), (b)(6), and (b)(6).Associated di: (b)(4).Lot number 6462310, 6462311, and 6462405.The report summarizes 3 malfunction events involving aspirators & air com (hcs7001).Customer reported that ¿low pressure.¿ medline quality received three units of hcs7001; the samples appeared to be in used condition, were plugged into a power source and turned on, one unit suctioned properly and met specs, and two units ran loud and do not meet product specifications; when opened to check for internal damages and defects, a loose piston was observed inside all the units.The reported problem was confirmed for the units that did not meet product specifications, and based on the sample and complaint details the root cause is considered to be a vendor product issue relating to the manufacturing process.Our quality team will monitor this issue for trending purposes, this 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: 50871770
• Report Number: 1417592-2026-49197
• Device Sequence Number: 10690655
• 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
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2024
• 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: 12/23/2024
• Initial Report FDA Received Date: 09/23/2026
• 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