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

Catalog Number	DYNDV1615I
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "defective extension set tubing was cut / sliced when used for the first time to pull blood from a pt.".
Additional Manufacturer Narrative
The account reported finding slice in tubing, and no medical intervention, serious injury, or follow-up care has been reported.Two photos were provided to aid in the investigation; finished good production records were reviewed, and no non-conformances were noted that could have contributed to the reported issue, and finished good pack build was reviewed with no sharp objects or components present within the pack.Photos were provided demonstrating a partial slice in the clear tubing, confirming the reported issue.Based on the investigation, it is unlikely that placement contributed to the reported issue; the item was either damaged prior to placement in the pack and was not noted during assembly or the item became damaged due to rough handling, and with the information available, medline was unable to determine at what point the component was sliced.The division 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 W/EXT SET KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50777997
• Report Number: 1417592-2026-41247
• Device Sequence Number: 21498861
• Product Code: LRS
• UDI-Device Identifier: 10195327407100
• UDI-Public: 10195327407100
• 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): 09/15/2026

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: DYNDV1615I
• Device Lot Number: 25LBL099
• Was Device Available for Evaluation?: No
• 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: 02/11/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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