MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PRESSUREPLUS INFUSION BAG, 1000ML

Catalog Number	DYNJPI1000C
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The bag doesn't hold air.
Additional Manufacturer Narrative
It was reported that the bag doesn't hold air.This is when aired up to desired pressure and then stop cock turned as directed, the bag still loses air and does not proved pressure.Tried another contacted another unit to get another to use.Switched out with bp cuff and aired to desired pressure.The pressure bag was faulty so we had to resort to putting a blood pressure cuff on to provide a pressure bolus to the patient.This happened on lots of patients.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.

• Brand Name: MEDLINE
• Common Device Name: PRESSUREPLUS INFUSION BAG, 1000ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25588198
• Report Number: 1417592-2026-02920
• Device Sequence Number: 5381624
• Product Code: KZD
• UDI-Device Identifier: 10193489033106
• UDI-Public: 10193489033106
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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: DYNJPI1000C
• Device Lot Number: 81725110003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown