MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID,HAND HELD,NYLON CASE,PURPLE

Catalog Number	MDS9113
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the bladder is not inflating".
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving a medline hand held aneroid that was not inflating during use.Medline received the handheld aneroid in used condition and, upon visual inspection of the sample, confirmed that there was a hole located at the end of a tubing that connects to the bladder; the complaint was confirmed.The cuff failed to inflate due to the hole allowing for air to be released, and the issue shown via investigation was most likely caused due to excessive bending around that area during uses.The sample did not operate as intended; per vendor, through internal investigation, no abnormalities were found and the complaint could not be confirmed.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,HAND HELD,NYLON CASE,PURPLE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: cyrus johnson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50774808
• Report Number: 1417592-2026-40761
• Device Sequence Number: 18747493
• Product Code: DXQ
• UDI-Device Identifier: 00080196357140
• UDI-Public: 00080196357140
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/10/2026

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: MDS9113
• Device Lot Number: 65121030002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2025
• 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: 02/13/2025
• 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