MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MONITOR,BP,WRIST,DIGITAL UNIT

Catalog Number	MDS3003
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "bp monito does not work" and "bp monitor does not reap bp correctly".
Additional Manufacturer Narrative
The patient stated the bp monitor does not work, and jess stated an rn went to the patient's home and stated the bp monitor does not reap bp correctly.The complaint investigation reviewed the details provided, but there were no samples or pictures received and no samples, photos, videos, lot numbers, or other critical details provided, even after follow-ups with the customer.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications; without a sample received it is difficult to determine a true root cause for the reported issue.The division performs quarterly trending on all complaints received, and if a sample, photo, and/or additional information becomes available, this complaint will be reopened to be further investigated.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: MONITOR,BP,WRIST,DIGITAL UNIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856393
• Report Number: 1417592-2026-47870
• Device Sequence Number: 13245851
• Product Code: DXN
• UDI-Device Identifier: 10080196525188
• UDI-Public: 10080196525188
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K183535
• 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): 09/22/2026

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: MDS3003
• Was Device Available for Evaluation?: Yes
• 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: 09/05/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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