MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID, HAND HELD PALM, HP

Catalog Number	MDSANEROIDHP
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the issue is the device not holding the pump to get the dial to move.We are not sure if this is because the pump itself or the tubing connections.".
Additional Manufacturer Narrative
The account reported finding aneroid unable to hold pump; the complaint stated the device was not holding the pump to get the dial to move and staff were concerned about the accuracy of the results because it was challenging to pump the device.Photos were provided; the first photo depicted the pump alongside its guage, but a physical sample would be needed to test and evaluate, and the vendor's internal investigation, including dhr review and inspection records review, found no abnormalities.The complaint was not confirmed, and an exact cause of the issue could not be determined from the photos provided.No further actions are required, and divisional qa will continue to monitor during monthly and quarterly trending.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: ANEROID, HAND HELD PALM, HP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804950
• Report Number: 1417592-2026-43779
• Device Sequence Number: 12910721
• Product Code: DXQ
• UDI-Device Identifier: 00888277656737
• UDI-Public: 00888277656737
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K211084
• 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): 09/17/2026

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: MDSANEROIDHP
• Device Lot Number: 65125050002
• Was Device Available for Evaluation?: Yes
• 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: 02/12/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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