MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MONITOR,BP,AUTO,DIGITAL,ADULT

Catalog Number	MDS3001
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there air leak in the hose near cuff.She found a hole where the hose inserts into the cuff.".
Additional Manufacturer Narrative
The customer reported an air leak in the hose near cuff and found a hole where the hose inserts into the cuff.A sample/photo was provided, and the investigation stated that medline received the bp monitor in used condition.The investigation results were unconfirmed, and the complaint was not confirmed.No confirmed root cause was identified; the investigation stated the unit was out of warranty and that because the sample is over 2 years old, this is most likely the reason why the sample has started to show signs of malfunction and wear/tear, and the division will continue to monitor the issue for trending.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,AUTO,DIGITAL,ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ankitha komirishetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869423
• Report Number: 1417592-2026-48849
• Device Sequence Number: 10715150
• Product Code: DXN
• UDI-Device Identifier: 10080196525140
• UDI-Public: 10080196525140
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K183534
• 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: MDS3001
• Device Lot Number: 43321080004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2024
• 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: 08/12/2024
• Initial Report FDA Received Date: 09/23/2026
• 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