MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 3000ML,PRESSURE INFUSER W/THUMBWHEEL

Catalog Number	DYNJAAPI3000T
Medical Device Problem Codes	Burst Container or Vessel (1074); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have the medline brand (b)(6)and they are not staying inflated.".
Additional Manufacturer Narrative
The account reported the medline brand pressure infusers were ¿not staying inflated¿; according to the facility, sometime in 2024, a 3l pressure bag started leaking air when inflating it and another bag burst, with no patient involvement.A sample was received for investigation; all three samples were inspected for damage/defects, none were found, each sample was tested with a 2000ml iv bag, the pressure infuser bag was inflated to its maximum and the pressure was maintained, and there were no leaks detected; the pressure indicator was not functioning while inflating the bag and did not move to signify fill range.Medline was not able to confirm the quality issue with regards to the pressure infuser bags holding pressure; however, there were other issues found that do confirm the product is not working properly.The root cause for the reported issue was not confirmed with the received sample, and the complaint was provided to the component manufacturing facility for further evaluation while the quality team 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: 3000ML,PRESSURE INFUSER W/THUMBWHEEL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50855238
• Report Number: 1417592-2026-47669
• Device Sequence Number: 9497747
• Product Code: KZD
• UDI-Device Identifier: 40080196759683
• UDI-Public: 40080196759683
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: DYNJAAPI3000T
• Device Lot Number: 65122040006
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/29/2024
• 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: 07/25/2024
• 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