MAUDE Adverse Event Report: Medline Industries, LP Medline; ASPIRATOR,SUCTION,VAC-ASSIST

Catalog Number	HCS7000
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: ASPIRATOR,SUCTION,VAC-ASSIST
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50068220
• Report Number: 1417592-2026-08005
• Device Sequence Number: 10078506
• Product Code: JCX
• UDI-Device Identifier: 40080196769293
• UDI-Public: 40080196769293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: HCS7000
• Device Lot Number: 014008019676929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown