MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-PRE OP KIT W/O NACL

Catalog Number	DYKS1526
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "some of the nasal cannulas are shorter than the others" and "iv tubing top snaps off causes leaking fluids.".
Additional Manufacturer Narrative
The account reported finding incorrect component and that the iv tubing snaps off; the customer also reported that the issues have happened multiple times over the past few weeks and no patients were harmed.No sample or photo was received for the investigation; finished good production records were reviewed, and there were no substitution approvals, line downs, deviations or nonconformance reports that might have had an impact on this issue, and the finished good pack build was reviewed.Without a sample/picture of the reported components, medline was unable to accurately determine the incident.The cause was unconfirmed, and a sample was required to determine cause; division to monitor 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: DBD-PRE OP KIT W/O NACL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50668096
• Report Number: 1417592-2026-33588
• Device Sequence Number: 18680309
• Product Code: OJU
• UDI-Device Identifier: 40195327584710
• UDI-Public: 40195327584710
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/03/2026

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: DYKS1526
• Device Lot Number: 24BDE069
• 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: 05/16/2024
• Initial Report FDA Received Date: 09/08/2026
• 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