MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PRESSURE MONITORING KIT - 60IN

Catalog Number	DYNJTRANS60
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported product problem/issue was leakage, with the account reporting leak observed from bonding joint between the tubing and the female connection.No stock check was required, as this was a sample build, and no sample was received for evaluation; a 6-month review of complaint history revealed 0 similar complaints reported by the customer account and 0 similar complaints reported against the finished good part number.Based on the investigation results, the reported event was not able to be confirmed at this time as there was no sample returned for evaluation.Root cause remains inconclusive at this time as the reported defect was not able to be confirmed, and medline will continue to monitor for additional occurrences and adverse trends.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.
Event or Problem Description
It was reported that "leak observed from the bonding joint between the tubing and the female connection.".

• Brand Name: MEDLINE
• Common Device Name: PRESSURE MONITORING KIT - 60IN
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50945421
• Report Number: 1417592-2026-54075
• Device Sequence Number: 10451573
• Product Code: DXJ
• UDI-Device Identifier: 40889942582618
• UDI-Public: 40889942582618
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K883718
• 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): 09/29/2026

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: DYNJTRANS60
• Was Device Available for Evaluation?: Yes
• 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: 03/29/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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