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

Catalog Number	MDS9400
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the cuff has another leak"; "and when it reached 180 the needle started to fall without them releasing the air themselves"; and "they could hear and feel the air leaking from the cuff.".
Additional Manufacturer Narrative
The customer reported receiving a medline hand held aneroid that is leaking, and reported that when it reached 180 the needle started to fall without them releasing the air themselves and they could hear and feel the air leaking from the cuff.Medline received 1ea medline hand held aneroid; the sample came without a gauge, and once it was replaced and set for testing, medline attempted to inflate to 300mmhg.The complaint was confirmed: the sample had an audible leak and would not inflate, and the sample did not work as intended.The cause was documented as "comp./part defective, broke" and confirmed supplier caused; the sku/lot falls under a known issue for leakage, necessary corrective actions are being implemented with the vendor.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,WALL MOUNT,ADULT CUFF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdulrahim ghaffar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50747993
• Report Number: 1417592-2026-38906
• Device Sequence Number: 12897280
• Product Code: DXQ
• UDI-Device Identifier: 30080196771268
• UDI-Public: 30080196771268
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/13/2026

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: MDS9400
• Device Lot Number: 65123080002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2025
• 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: 06/10/2025
• Initial Report FDA Received Date: 09/14/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown