MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SET, BP, CUFF, BLD, PVC, 2T, LG ADL

Catalog Number	MDS91423
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Other
Event or Problem Description
It was reported that "cuffs stopped functioning within a week.The bulb attached to the tubing will not reopen, the cuffs do not hold air pressure.".
Additional Manufacturer Narrative
The customer reported the cuffs stopped functioning within a week; the bulb attached to the tubing will not reopen, and the cuffs do not hold air pressure.No samples or pictures were received, and no sample, photo, and/or additional information became available after follow-ups with the customer.The complaint could not be confirmed, and medline was unable to confirm the complaint issue or that the product failed to meet specifications.Without a sample received it is difficult to determine a true root cause for the reported issue; no trends were identified for the specified material number and its corresponding defect type.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: SET, BP, CUFF, BLD, PVC, 2T, LG ADL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50932209
• Report Number: 1417592-2026-53028
• Device Sequence Number: 13451784
• Product Code: DXQ
• UDI-Device Identifier: 10080196717613
• UDI-Public: 10080196717613
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: MDS91423
• Was Device Available for Evaluation?: Yes
• 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: 03/09/2023
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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