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

Catalog Number	DYND74268
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tegaderm is not sticking to the patient and when they go to peel the backing off it either does not come off or the backing comes off but the tegaderm stays stuck to it and the nurse is unable to peel it.".
Additional Manufacturer Narrative
The customer reported the tegaderm is not sticking to the patient and the backing either does not come off or the backing comes off but the tegaderm stays stuck to it and the nurse is unable to peel it.No sample or photo was received for the investigation; finished good production records and finished good pack build were reviewed, and there were no issues identified 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: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50805808
• Report Number: 1417592-2026-43881
• Device Sequence Number: 20993657
• Product Code: LRS
• UDI-Device Identifier: 40080196860440
• UDI-Public: 40080196860440
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/16/2026

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: DYND74268
• 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: 04/24/2024
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (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