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

Catalog Number	DYNJAAPI500S
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact, "the pressure bag does not hold pressure, even with dead ender cap on air intake valve." the anesthesia manager stated that the "air is leaking where tubing meets the bag." per the facility, this "results in loss of hemodynamic monitoring.No sentinel events/patient harm have occurred" however required "clinical intervention to replace swan-ganz lines within the icus." no additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer contact, "the pressure bag does not hold pressure, even with dead ender cap on air intake valve.".

• Common Device Name: 500ML,PRESSURE INFUSER W/STOPCOCK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23780219
• Report Number: 1417592-2025-00709
• Device Sequence Number: 10105569
• Product Code: KZD
• UDI-Device Identifier: 10080196759699
• UDI-Public: 10080196759699
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAAPI500S
• Device Lot Number: 81725040003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown