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

Catalog Number	MDS9400
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the cuff is not holding air and it deflates as they are pumping it up.".
Additional Manufacturer Narrative
The customer reported the cuff was not holding air and it deflated as they were pumping it up.Medline received 1ea wall mount aneroid in used condition, tested the sample according to the instructions for use, attempted to inflate the cuff, noticed an air leak on the opposite side where the tubing and the bladder connects, and removed the bladder from the cuff.The complaint was confirmed, and a tear along the seam was confirmed.The issue shown via investigation was caused by a weak seam allowing the bladder to open; the sample did not work as intended.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: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50775574
• Report Number: 1417592-2026-40861
• Device Sequence Number: 21444029
• Product Code: DXQ
• UDI-Device Identifier: 30080196771268
• UDI-Public: 30080196771268
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/11/2026

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: 65122110002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/19/2023
• 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: 04/12/2023
• Initial Report FDA Received Date: 09/15/2026
• 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