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

Catalog Number	DYNJAAPI1000S
Medical Device Problem Codes	Deflation Problem (1149); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "bags are not holding pressure".
Additional Manufacturer Narrative
The account reported that the pressure infuser bags were not holding pressure.A sample was received; the bag was inspected for any defects and none were found, filled to 300mmhg and closed off with the attached clamp, compressed with no signs of pressure loss, and then deflated with no issue; this cycle was repeated two more times with the same result.The reported issue was not confirmed, and the cause was documented as not confirmed with received sample.Our quality team will monitor this issue for trending purposes, and there has been no change to the reportability decision associated with this complaint.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: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854746
• Report Number: 1417592-2026-47574
• Device Sequence Number: 13250137
• Product Code: KZD
• UDI-Device Identifier: 40080196759621
• UDI-Public: 40080196759621
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: DYNJAAPI1000S
• Device Lot Number: 65123090002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2024
• 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: 03/13/2024
• 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