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

Catalog Number	DYNJAAPI500S
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the new pressure infusor bags 1000ml size from medline are not holding pressure, and are slowly leaking air during cases.".
Additional Manufacturer Narrative
The customer reported that the pressure infuser bags were not holding pressure and were slowly leaking air during cases, and staff had been using hemostats to clamp the tubing tight.A sample was received; to evaluate for the reported issue, medline inflated the pressure bag and set the valve to the up position to maintain pressure, per the ifu, and the pressure indicator showed 250 mm hg and after one hour remained at 250 mm hg.Finished good production records and retained samples were reviewed, and the manufacturer did not find any discrepancies or defects that could have contributed or caused the reported issue.Based on the complaint details, sample evaluation, and investigation, the complaint is not confirmed, 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: 500ML,PRESSURE INFUSER W/STOPCOCK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50852788
• Report Number: 1417592-2026-47276
• Device Sequence Number: 13245945
• Product Code: KZD
• UDI-Device Identifier: 10080196759699
• UDI-Public: 10080196759699
• 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): 09/21/2026

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: DYNJAAPI500S
• Device Lot Number: 81725070002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2025
• 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: 11/14/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown