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

Catalog Number	MDS9388
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was misreading.
Additional Manufacturer Narrative
Customer reported that it was misreading.Medline received 1ea handheld aneroid in like-new condition, performed a visual inspection, and tested the sample by inflating it up to 300 mmhg; the test was repeated five times.During testing the cuff was able to inflate and deflate properly and the dial measured properly, and no signs of leaks or any other defects preventing the cuff and gauge to work as intended were observed.The complaint was not confirmed; the cause code description was not confirmed with received sample, and division has been informed and will continue to monitor trends.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,LRG ADULT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50896698
• Report Number: 1417592-2026-50742
• Device Sequence Number: 17599665
• Product Code: DXQ
• UDI-Device Identifier: 10080196177813
• UDI-Public: 10080196177813
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: MDS9388
• Device Lot Number: 6512307000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2024
• 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: 01/12/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown