MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANEROID,HAND HELD,SPRAGRAP,STETH,BLACK

Catalog Number	MDS9125
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that item is defective bp cuff does not work.
Additional Manufacturer Narrative
The reported issue was does not inflate, and the customer stated the bp cuff does not work.Medline received one compli-mates combination kit in used condition, tested the cuff according to the instructions for use, inflated the sample numerous times up to 300mmhg, observed no air leaks, confirmed the gauge was displaying readings as intended and the needle was moving freely, and conducted a pressure test using a bp simulator.The complaint was not confirmed, and the cause code was updated to reflect unconfirmed defect - not confirmed with received sample.Medline saw no issues during testing, and the sample worked 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,SPRAGRAP,STETH,BLACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50771547
• Report Number: 1417592-2026-40318
• Device Sequence Number: 15820580
• Product Code: DXQ
• UDI-Device Identifier: 00080196170053
• UDI-Public: 00080196170053
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/14/2026

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: MDS9125
• Device Lot Number: 65122100001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/03/2023
• 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: 06/28/2023
• 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