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

Catalog Number	MDS9380LF
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 bp cuffs not working properly.Not holding air.
Additional Manufacturer Narrative
The customer explained that the cuffs are not holding air.We received 1 ea (b)(6) handheld pvc aneroids; cuff was inspected for any holes, and no damage was observed to cuff, bulb, tubing, or dial.Testing was then performed by inflating cuff to 300mmhg; after cuff was inflated, valve was opened to deflate, and leaking did not occur prior to opening valve.The complaint was not confirmed, 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,ADULT,NEOPRENE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50877266
• Report Number: 1417592-2026-49599
• Device Sequence Number: 9426188
• Product Code: DXQ
• UDI-Device Identifier: 10080196738922
• UDI-Public: 10080196738922
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: MDS9380LF
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2023
• 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: 09/28/2023
• Initial Report FDA Received Date: 09/24/2026
• 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