MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ASSEMBLY,BULB & VALVE

Catalog Number	MDS91482
Medical Device Problem Codes	Inflation Problem (1310); Obstruction of Flow (2423); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿one is collapsed, and they have tried to problem solve however we cannot get it to inflate and therefore cannot use.¿.
Additional Manufacturer Narrative
The customer reported one is collapsed, and they have tried to problem solve however they cannot get it to inflate and therefore cannot use.Medline received 1ea bulb assembly and valve in used condition and tested the sample according to the instructions for use; when attempting to inflate the cuff, the inflation bulb would not inflate the cuff as intended, the bulb appeared to be delated, and air could not be put back in the bulb.The complaint was confirmed.Issue shown via investigation was caused by a defective inflation bulb, due to the air mechanism being blocked; the sample did not work as intended, 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: ASSEMBLY,BULB & VALVE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50771042
• Report Number: 1417592-2026-40288
• Device Sequence Number: 9471889
• Product Code: DXQ
• UDI-Device Identifier: 10080196717736
• UDI-Public: 10080196717736
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/10/2026

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: MDS91482
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2024
• 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: 04/22/2024
• 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