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

Catalog Number	MDS9387
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the first time trying while pushing the ball, the needle wasn't moving at all"; "when tried the second time the needle got stuck"; "then went opposite of where it was supposed to go.".
Additional Manufacturer Narrative
The customer reported receiving medline handheld child aneroid whose needle was getting stuck during use; the first time trying while pushing the ball, the needle wasn't moving at all, and when tried the second time the needle got stuck and went opposite of where it was supposed to go.Medline received one handheld child aneroid in used condition; visual inspection did not reveal any manufacturing defects, the needle was calibrated at the start position, and the sample was tested according to the instructions for use by inflating five different times up to 300mmhg.During testing, the needle moved up and down at the same time the cuff was being inflated and deflated, no issues were experienced, and the sample was able to inflate and deflate the control cuff and display readings as intended.The complaint was not confirmed with the received sample; based on the review, medline was 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,HAND HELD,CHILD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: connor klawikowski ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50899533
• Report Number: 1417592-2026-51157
• Device Sequence Number: 17599596
• Product Code: DXQ
• UDI-Device Identifier: 10080196177745
• UDI-Public: 10080196177745
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/24/2026

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: 65125050001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/16/2025
• 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: 09/29/2025
• 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