MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID,HAND HELD,CHILD

Catalog Number	MDS9387
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the sphygmomanometer dial is on the 300 marks.It needs to be even at the 0 to read properly.".
Additional Manufacturer Narrative
The customer reported receiving a medline hand held aneroid with readings off and stated the sphygmomanometer dial is on the 300 mark and needs to be even at the 0 to read properly.Medline received one sample and performed accuracy testing using a fluke bp pump with a built in manometer, checked for matching values on the gauge and the bp pump, measured the cuff at points 180, 200, and 300, and observed for leakage.No leakage was observed and gauge readings matched the set fluke parameters; the complaint was not confirmed.The gauge needle was off the set resting mark when received, the cuff was recalibrated before testing, and the sample is working as intended.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,CHILD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869984
• Report Number: 1417592-2026-48984
• Device Sequence Number: 18814111
• Product Code: DXQ
• UDI-Device Identifier: 10080196177745
• UDI-Public: 10080196177745
• 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): 09/23/2026

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: MDS9387
• Device Lot Number: 65125010002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/01/2025
• 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: 04/24/2025
• Initial Report FDA Received Date: 09/23/2026
• 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