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

Catalog Number	DYNDV1719C
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "backing window is coming off, tegaderm sticky piece coming off with it.Not sticking correctly.".
Additional Manufacturer Narrative
The customer reported that the backing window was coming off and the tegaderm sticky piece was coming off with it, was not sticking correctly, and the incident occurred during patient use; there was no report of any patient injury or adverse event.No sample or photo was received for the investigation; finished good production records were reviewed with no run without approvals, deviations or non-conformance reports that might have had an impact on this issue, and finished good pack build was reviewed with no issues that likely contributed to the reported issue.The reported issue could not be confirmed without a sample.Due to other reports received, the likely root cause is a vendor issue relating to their manufacturing process, and medline is working with the component manufacturing facility for further evaluation and corrective actions.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: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856401
• Report Number: 1417592-2026-47875
• Device Sequence Number: 9936685
• Product Code: OJH
• UDI-Device Identifier: 40889942916406
• UDI-Public: 40889942916406
• 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): 09/22/2026

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: DYNDV1719C
• Device Lot Number: 24ABU677
• 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: 04/05/2024
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown