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

Catalog Number	RWM-IV01
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	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when they try to unpeel the tegaderm the exterior comes off, but the part that is suppose to go on the patient is not coming off.
Additional Manufacturer Narrative
The customer reported that when they try to unpeel the tegaderm the exterior comes off, but the part that is suppose to go on the patient is not coming off.A photo and a sample were received; in the photo two tegaderm backings were depicted and on both of them a film was observed hanging on them, and sample evaluation found the dressing in the kit was missing the paper frame and was stuck to the liner backing.The investigation confirmed the vendor and the cause of this issue; the issue derives from the raw materials process when the force between frame liner and the film is too weak.Finished good production records and finished good pack build were reviewed, and there were no issues identified that likely contributed to the reported issue.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/TRNSPRNT DRSG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868730
• Report Number: 1417592-2026-48742
• Device Sequence Number: 18809918
• Product Code: LRS
• UDI-Device Identifier: 40889942582021
• UDI-Public: 40889942582021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: RWM-IV01
• Device Lot Number: 24ABE070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2024
• 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: 03/15/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (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