MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID,MOBILE,ADULT CUFF

Catalog Number	MDS9407
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 2 malfunction events that occurred between (b)(6) and (b)(6), 2025.The account reported that mobile aneroid blood pressure monitors (mds9407) produced hissing noises and were unable to obtain blood pressure readings due to inflation failure.No patient information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 2 malfunction events that medline became aware of during (b)(6) and (b)(6), 2025.Associated lot numbers 65124050003 and 65124060001.2 mds9407 mobile aneroid blood pressure monitors were returned for evaluation following reports of hissing noises and failure to obtain blood pressure readings.Medline quality received and evaluated 2 devices in used condition.Visual inspection confirmed a hole at the end of the tubing connecting to the bladder in each cuff.Functional evaluation demonstrated that the cuffs were unable to inflate because air escaped through the tubing defect.Based on the investigation, the reported issue was confirmed for both devices.The affected lot numbers fall under scar-00444 for cuff inflation-related issues, and corrective actions with the supplier were already in progress.Replacement product was issued under sales order 1106359184.2 devices were returned for evaluation.The devices were not labeled for single use.No devices were identified as reprocessed or reused.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,MOBILE,ADULT CUFF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884885
• Report Number: 1417592-2026-50090
• Device Sequence Number: 18598571
• Product Code: DXQ
• UDI-Device Identifier: 40080196771333
• UDI-Public: 40080196771333
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• 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: MDS9407
• 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: 09/02/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown