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

Catalog Number	MDS9407
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both machines have tiny holes in the cuff itself.You can hear the pressure increasing but the air is escaping from the cuff.
Additional Manufacturer Narrative
The customer reported receiving adult mobile aneroids that hole in the cuff and would not inflate during use.Medline received two adult mobile aneroids (bladder and inflation bulb only) in used condition, attached a control gauge to the cuffs, tested the samples according to the instructions for use, and tried to inflate each bladder.The complaint was confirmed; medline was unsuccessful in inflating each bladder, confirmed that they had an air leak, and upon closer visual inspection noticed the samples had a tear along the seam on the opposite side of the tubing.The cause was cannot determine cause with received sample; per vendor, through internal investigation including dhr review and inspection records review, no abnormalities were found and the complaint could not be confirmed, and the division will continue to monitor trends.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: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870039
• Report Number: 1417592-2026-48998
• Device Sequence Number: 21518393
• Product Code: DXQ
• UDI-Device Identifier: 40080196771333
• UDI-Public: 40080196771333
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/23/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2025
• 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: 10/14/2025
• 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