MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 500ML,PRESSURE INFUSER W/STOPCOCK

Catalog Number	DYNJAAPI500S
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that medline 500ml pressure bag with stopcock valve, not effectively holding air despite stop cock being in the correct "off" position.The pressure bag is slowly losing air over time requiring nurse to frequently reinflate and check on pressure.
Additional Manufacturer Narrative
It was reported that ¿the pressure bag is slowly losing air over time requiring nurse to frequently reinflate and check on pressure.Additionally, when trying to overinflate the pressure indicator into the red, you could audibly hear it release air.We thought maybe the bag had an air leak so we switched out the bag to a new one, but it was doing the same thing.¿ 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: 500ML,PRESSURE INFUSER W/STOPCOCK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: durga duduku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853369
• Report Number: 1417592-2026-47346
• Device Sequence Number: 13138594
• Product Code: KZD
• UDI-Device Identifier: 40080196759690
• UDI-Public: 40080196759690
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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): 09/21/2026

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: DYNJAAPI500S
• Device Lot Number: 651240060001
• 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: 12/02/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown