MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; 1000ML,PRESSURE INFUSER W/STOPCOCK

Catalog Number	DYNJAAPI1000S
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "2ea of the bags are leaking.".
Additional Manufacturer Narrative
The account reported finding "leaking bags"; the complaint transcript stated the issue did not occur during use and no injury occurred.Medline quality received two samples, visually inspected the samples for damage, defects or deformities and none were found, then attempted to inflate the bags to the desired pressure but the bags would not inflate properly; upon inspection, the bags had small slices where air was leaking out, which prevented proper inflation.The reported issue was confirmed; however, the root cause could not be determined based on the complaint information and samples provided, and based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process.The quality team will monitor this issue for trending purposes, the complaint was provided to the vendor/manufacturer for further evaluation, and reportability has not changed.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: 1000ML,PRESSURE INFUSER W/STOPCOCK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50882640
• Report Number: 1417592-2026-49716
• Device Sequence Number: 18817706
• Product Code: KZD
• UDI-Device Identifier: 10080196759620
• UDI-Public: 10080196759620
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/23/2026

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: DYNJAAPI1000S
• Device Lot Number: 65125030002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/19/2025
• 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: 09/10/2025
• Initial Report FDA Received Date: 09/24/2026
• 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