MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; 1000ML,PRESSURE INFUSER W/STOPCOCK

Catalog Number	DYNJAAPI1000S
Medical Device Problem Codes	Decrease in Pressure (1490); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, the pressure bag slowly deflated.The "pressure was set to 300mmhg for arterial line.Patient's bp via the arterial line was noted to be lower than previous readings, waveform dampened, line was flushed and recalibrated, pressure bag noted to deflate to 200mmhg." this occurred twice in 1 hour span.The facility reports there was no serious injury or medical intervention required as a result of this incident.Per the facility, the patient passed away, however "not from any complications of this incident." 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 facility, on (b)(6) 2025, the pressure bag slowly deflated.The "pressure was set to 300mmhg for arterial line.Patient's bp via the arterial line was noted to be lower than previous readings, waveform dampened, line was flushed and recalibrated, pressure bag noted to deflate to 200mmhg.".

• Brand Name: MEDLINE
• Common Device Name: 1000ML,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: 24058535
• Report Number: 1417592-2026-00040
• Device Sequence Number: 9421836
• Product Code: KZD
• UDI-Device Identifier: 10080196759620
• UDI-Public: 10080196759620
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/13/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAAPI1000S
• Device Lot Number: 81725050001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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
• Patient Age: 39 YR
• Patient Sex: Male