MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID,HANDHELD,PREMIER,ADULT

Catalog Number	MDS9410
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "product no longer holding air when using.Product will deflate and not take accurate blood pressure reading.".
Additional Manufacturer Narrative
The customer reported receiving a medline handheld aneroid that was not giving accurate readings during use, and that the device was not "holding air" preventing the ability to obtain a blood pressure reading; the customer reported that they were able to use an alternate device to obtain a measurement, and no injury occurred.Medline received one medline handheld aneroid in used condition, tried to inflate the sample but it rapidly deflated, failing to hold any air inside the bladder, then removed the bladder from the cuff and confirmed that it had a tear along the seam at the opposite side of the tubing.The complaint was confirmed; the sample did not work as intended, and the cause code description was comp./part defective, broke.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,HANDHELD,PREMIER,ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50771474
• Report Number: 1417592-2026-40304
• Device Sequence Number: 15808606
• Product Code: DXQ
• UDI-Device Identifier: 00080196773193
• UDI-Public: 00080196773193
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: MDS9410
• Device Lot Number: 65124100002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2025
• 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: 05/01/2025
• 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