MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUFF, BP, DIS, 1T, CHI, HP

Catalog Number	MDS9911HP
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood pressure cuff appeared to have an air leak and would not read on the monitor.
Additional Manufacturer Narrative
A complaint was received related to a "leaking air"; according to the facility, the blood pressure cuff appeared to have an air leak and would not provide a reading on the monitor during use.The sample was received in used condition, visual inspection did not show any signs of damage or broken parts, and the sample was inflated to 300mmhg and rapidly deflated not holding the pressure.The complaint was confirmed.Per vendor investigation report, after cutting open the cuff, damage was found at the corresponding point on the internal pvc membrane, which is the direct cause of the leak; batch-wide material quality abnormality has been ruled out through inspection, this defect is an isolated individual issue, and it is concluded that the root cause of this cuff leak is external force causing a scratch or puncture to the pvc membrane.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: CUFF, BP, DIS, 1T, CHI, 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: 50804164
• Report Number: 1417592-2026-43620
• Device Sequence Number: 12897401
• Product Code: DXQ
• UDI-Device Identifier: 10884389194782
• UDI-Public: 10884389194782
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161035
• 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: MDS9911HP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2026
• 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: 02/27/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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