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

Catalog Number	MDS9411
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gauge gives false readings even when there is no inflation.
Additional Manufacturer Narrative
The customer reported receiving a medline child hand held aneroid that was giving false readings during use; there was no reported death or serious injury associated with this event.We received 1ea child hand held aneroid in used condition, noticed the needle was off from the start position, repositioned the needle to zero-off position, and tested the aneroid according to the instructions for use by inflating and deflating up to 300mmhg several times.The complaint was not confirmed; no issues were seen during testing, the cuff was inflated/deflated as normal, and the sphygmomanometer worked properly.The cause code description was not confirmed with received sample, and based on the review of the details provided for the complaint investigation, we are 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,CHILD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50895700
• Report Number: 1417592-2026-50665
• Device Sequence Number: 6001477
• Product Code: DXQ
• UDI-Device Identifier: 00080196743745
• UDI-Public: 00080196743745
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/23/2026

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: MDS9411
• Device Lot Number: 65124120002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2025
• 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: 07/09/2025
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown