MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PRESSUREPLUS INFUSION BAG, 500ML

Catalog Number	DYNJPI500C
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the bag was reported to be leaking air.".
Additional Manufacturer Narrative
The account reported finding leaking air with the pressureplus infusion bag, 500ml.A sample was received and evaluated by inflating the pressure bag, recording the pressure reading at that time, and then coming back after five hours to record the pressure reading; the pressure readings remained the same (300mmhg).The complaint is not confirmed, and the manufacturer did not find any discrepancies or defects in the production records or retained samples that could've contributed or caused the reported issue.From the evaluation, the device did not lose any air since the pressure gauge provided the same reading before and after the device was kept inflated for five hours.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: PRESSUREPLUS INFUSION BAG, 500ML
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691703
• Report Number: 1417592-2026-34741
• Device Sequence Number: 5975619
• Product Code: KZD
• UDI-Device Identifier: 10193489033113
• UDI-Public: 10193489033113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/04/2026

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: DYNJPI500C
• Device Lot Number: 81725080003
• 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: 06/23/2026
• Initial Report FDA Received Date: 09/09/2026
• 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