MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUFF, BP, REUSE, 1T, LG ADL, HP

Catalog Number	MDS9914HPRE
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cuffs are over or underinflating and providing inaccurate reads.
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving medline bp reusable cuffs that are over or underinflating and providing inaccurate reads; there was no reported death or serious injury associated with this event.Medline received two reusable bp cuffs with the complaint of over or under inflating, contacted the manufacturer, and sent these for in depth testing; per the manufacturer, they retested the defective products according to the inspection standards and found that the cuff did not have insufficient or excessive inflation.Medline did not find any abnormalities or defects with the samples sent in from the customer, and the complaint is not confirmed.No root cause was identified; based on the review of the details provided for the complaint investigation, medline is unable to confirm the complaint issue or that the product failed to meet specifications.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: CUFF, BP, REUSE, 1T, LG ADL, HP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50917192
• Report Number: 1417592-2026-52280
• Device Sequence Number: 5804257
• Product Code: DXQ
• UDI-Device Identifier: 10888277360365
• UDI-Public: 10888277360365
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171889
• 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): 09/25/2026

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: MDS9914HPRE
• Device Lot Number: 20240811MST
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2025
• 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: 07/15/2025
• Initial Report FDA Received Date: 09/28/2026
• 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