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

Catalog Number	DYNJPI500C
Medical Device Problem Code	Unintended Deflation (4061)
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 "discovered pressure bag on arterial line deflated when earlier it was verified at appropriate pressure/clamped (only 2 hours since it was checked).".
Additional Manufacturer Narrative
The account reported finding pressure bag deflated, and the customer reported that new medline pressure bags with clamp are not maintaining necessary pressure for devices.A sample was received for investigation; the pressure bag was inflated to a pressure reading of 300 mmhg and the valve was set to maintain this pressure, and after 5 hours the pressure reading remained at 300 mmhg and the bag did not look to be deflated.Based on the complaint details, sample evaluation, and investigation, the complaint is not confirmed.Review of the sample did not confirm the reported issue--the pressure bag maintained air, and the division will monitor this issue for trending purposes.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: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50846475
• Report Number: 1417592-2026-46967
• Device Sequence Number: 18655291
• Product Code: KZD
• UDI-Device Identifier: 10193489033113
• UDI-Public: 10193489033113
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: DYNJPI500C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2026
• 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: 01/23/2026
• Initial Report FDA Received Date: 09/21/2026
• 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