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

Catalog Number	DYND74296
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	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have had many patients totally lose their iv sites due to the tape and tegaderms not adhering to the skin properly." "i tried wore a dressing for about two hours today and both the tape and the transparent dressings curled up at the edges.".
Additional Manufacturer Narrative
The account reported finding adhesive issue with dressings, and the complaint stated that patients totally lose their iv sites due to the tape and tegaderms not adhering to the skin properly.A photo was received for investigation; the dressing with transparent tape on the bottom and top of the dressing was adhered to the customer's arm, and the edges and corners of the dressing and tape were curling up away from the skin.Per the photos provided, the reported issue was confirmed, and no other defects or damage was observed.The cause was documented as sample required to determine cause, and the supplier quality team will monitor this issue for trending purposes.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
• 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: 50853924
• Report Number: 1417592-2026-47414
• Device Sequence Number: 9497713
• Product Code: LRO
• UDI-Device Identifier: 10193489191417
• UDI-Public: 10193489191417
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: KUNKOWN
• 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: DYND74296
• 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: 03/23/2023
• Initial Report FDA Received Date: 09/22/2026
• 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