MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-IV START KIT

Catalog Number	DYNDV2507
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that iv kit obtained for patient use and while assembling the int pigtail to flush the int hub disconnected from the line, defective line.
Additional Manufacturer Narrative
The customer reported a defective line: while assembling the int pigtail to flush, the int hub disconnected from the line; no injury was reported.Medline received no sample or photo for its investigation; finished good production records and finished good pack build were reviewed, and there were no run without approvals, deviations or non-conformance reports and no issues with the build that likely contributed to the reported issue.The initial investigation was unable to confirm the reported issue due to no sample or photo being received; vendor received 10 samples, tested the sets for leaks and pull tested to force separation, and no failures were realized, although the maxplus connectors were able to unscrew on 8 of the 9 sets it was attached to.The manufacturing team clarified that the maxplus is not glued or permanently fixed to the male luer of connecting tubing, the maxplus' ability to unscrew does not constitute a failure, and the root cause is due to normal device function; the device history record was also reviewed and there were no quality notifications issued for the failure mode reported by the customer during the build of this set.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-IV START KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093 ; +1(423)926-1171
• MDR Report Key: 50845690
• Report Number: 1417592-2026-46837
• Device Sequence Number: 13323941
• Product Code: LRS
• UDI-Device Identifier: 00653160348705
• UDI-Public: 00653160348705
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: DYNDV2507
• Device Lot Number: 2023010990
• 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: 05/04/2023
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (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