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

Catalog Number	DYKS1467
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	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the preop packs the tegaderm tape is sticking to the wrong side of the paper.A sample was received for investigation, and evaluation found 2 ea tegaderm dressings; on both of the dressings, the paper frame is not attached to the dressing itself so they're unable to be placed.Per the investigation, the vendor and the cause of this issue were confirmed.The issue derives from the raw materials process when the force between frame liner and the film is too weak, 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.
Event or Problem Description
It was reported that the preop packs the tegaderm tape is sticking to the wrong side of the paper.

• Brand Name: MEDLINE
• Common Device Name: DBD-PRE OP KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50756167
• Report Number: 1417592-2026-39519
• Device Sequence Number: 9668105
• Product Code: OJU
• UDI-Device Identifier: 40195327410194
• UDI-Public: 40195327410194
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/09/2026

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: DYKS1467
• Device Lot Number: 23JBW405
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2024
• 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: 03/04/2024
• Initial Report FDA Received Date: 09/14/2026
• 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