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

Catalog Number	MDS9411
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have a pediatric aneroid that is no longer holding air (bladder)".
Additional Manufacturer Narrative
The customer reported a pediatric aneroid that is no longer holding air (bladder).Medline received 1ea hand held aneroid and started testing by attempting to inflate each cuff to 300mmhg; the cuff would not make it past a quarter of inflation, then the bladder was removed from the cuff and the sample was further inspected.The complaint is confirmed, the sample is not working as intended, and a split on the cuff causing a leakage was found.The cause was identified as comp./part defective, broke.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 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50776631
• Report Number: 1417592-2026-41035
• Device Sequence Number: 10682952
• Product Code: DXQ
• UDI-Device Identifier: 00080196743745
• UDI-Public: 00080196743745
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/11/2026

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: 01/20/2026
• 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: 01/14/2026
• Initial Report FDA Received Date: 09/15/2026
• 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