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

Catalog Number	MDS9104
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	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿the bulb it is not delivering air to the cuff.".
Additional Manufacturer Narrative
The customer/reporter described the issue as not inflating and stated that the bulb was not delivering air to the cuff.The customer reported that they removed the output valve from the bulb, removed the rubber stopper that acts as a one way valve, inspected this stopper and reinstalled it, and now the bp cuff works fine; medline documented that the customer requested closure, having resolved the issue on their own.The reported problem was not confirmed by medline.The cause code was updated to reflect dc: traced to user - knowledge, and medline concluded this is no longer a quality issue.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,RED
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867183
• Report Number: 1417592-2026-48550
• Device Sequence Number: 13106360
• Product Code: DXQ
• UDI-Device Identifier: 00080196357119
• UDI-Public: 00080196357119
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/22/2026

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: MDS9104
• Device Lot Number: 65124100001
• 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: 05/06/2025
• Initial Report FDA Received Date: 09/23/2026
• 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