MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUFF,BP,UNIVERSAL,RANGES 22-42 CM

Catalog Number	MDS9974
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blood pressure cuff itself has devoloped a hole where the tube attaches to the cuff.
Additional Manufacturer Narrative
The customer reported receiving a medline universal bp cuff that had a hole in the tubing, and reported that the cuff developed a hole where the tube attaches to the cuff.Medline received the universal-sized bp cuff in used condition and not in the original packaging; upon visual inspection, medline confirmed that there was a hole where the tubing meets the bladder of the cuff, which made it so the cuff could not be inflated and the sample was unusable.The complaint was confirmed by medline, while the vendor stated that through internal investigation, including dhr review and inspection records review, no abnormalities were found and the complaint could not be confirmed.The cause was recorded as cannot determine cause with received sample, and the division 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: CUFF,BP,UNIVERSAL,RANGES 22-42 CM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50898470
• Report Number: 1417592-2026-50998
• Device Sequence Number: 5829455
• Product Code: DXQ
• UDI-Device Identifier: 00888277676070
• UDI-Public: 00888277676070
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K233276
• 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: MDS9974
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2025
• 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: 12/03/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown