MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV START KIT W/TAPE

Catalog Number	DYNDV1947
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the backing on the new suresite dressing is not pulling off properly.Sometimes it tears the whole dressing.".
Additional Manufacturer Narrative
The reported issue was adhesive issue dressing, with the backing on the new suresite dressing not pulling off properly and sometimes tearing the whole dressing.Per the investigation of the samples received, unused kits were returned for evaluation; dressings were removed from the kit, peeled from the release liner, and then applied to a laminate surface, and finished good production records were reviewed with no nonconformances noted by production or qc personnel.All of the dressings performed as expected, and the sample evaluation was unable to reproduce the reported issue.A root cause cannot be determined, and there has been no change to the reportability decision associated with this complaint.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: IV START KIT W/TAPE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50857595
• Report Number: 1417592-2026-48027
• Device Sequence Number: 9954113
• Product Code: LRS
• UDI-Device Identifier: 10889942148578
• UDI-Public: 10889942148578
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: DYNDV1947
• Device Lot Number: 2025013190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2025
• 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: 04/01/2025
• Initial Report FDA Received Date: 09/22/2026
• 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