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

Catalog Number	MDS9413
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there is an issue with the tubing on this cuff & it will not inflate".
Additional Manufacturer Narrative
The customer reported there is an issue with the tubing on this cuff and it will not inflate.Medline received one medline handheld aneroid in used condition; visual inspection confirmed a kink in the tubing that connects to the bladder, the tubing seemed "gummy", like it had been melted, and with a small amount of force the tubing ripped clean in half; samples were sent to the vendor, but were denied by customs as "used medical equiment," and the vendor completed dhr review and inspection records.The complaint was confirmed by medline; per vendor, dhr review and inspection records showed no abnormalities, and without samples, complaint could not be confirmed.The cause was documented as cannot determine cause w/received sample; the sample did not operate as intended, and division and vendor have been informed and 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,LRG ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804851
• Report Number: 1417592-2026-43759
• Device Sequence Number: 10590321
• Product Code: DXQ
• UDI-Device Identifier: 00080196743769
• UDI-Public: 00080196743769
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/16/2026

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: MDS9413
• Device Lot Number: 65123120001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2024
• 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: 04/12/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown