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

Catalog Number	MDS9410
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i have an adult bp cuff item # (b)(6) that has a leak and is unable to hold air.".
Additional Manufacturer Narrative
Per customer, the adult bp cuff has a leak and is unable to hold air.Medline received 1ea medline handheld aneroid in used condition; upon a visual inspection of the sphygmomanometer, the needle was standing at 300mmhg, the tubing was removed and a calibration tool was inserted to adjust the needle, then the tubing was attached again and the sample was tested according to the instructions for use.The complaint was not confirmed, and no root cause was identified.Medline saw no issues during testing, the sample was inflated up to 300mmhg and the needle came back to the zero-off position each time; 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: ANEROID,HANDHELD,PREMIER,ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803325
• Report Number: 1417592-2026-43457
• Device Sequence Number: 10548973
• Product Code: DXQ
• UDI-Device Identifier: 00080196773193
• UDI-Public: 00080196773193
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: MDS9410
• Device Lot Number: 65123050001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2024
• 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: 02/09/2024
• Initial Report FDA Received Date: 09/17/2026
• 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