MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 8", 1.6ML, NONBOND NF VALV

Catalog Number	DYNDTN2001
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "customer was using item and it was squirting fluid out of the port site.Appears to have crack or hole in port.".
Additional Manufacturer Narrative
According to the facility, "rn opened and primed iv extension tubing with saline while in package" and, upon flushing the extension set, "rn felt liquid splash on arm" and "there appeared to be a pinpoint hole in the tubing"; no injuries were sustained to patient or staff.A photo was received for the investigation, and the customer provided a video of the affected device; in the video, there appears to be a crack on the device where the tubing connects to the female luer, resulting in fluids leaking from the device.Based on the complaint details, video evaluation, and the investigation, the complaint is confirmed since leaking was observed from the device.Based on the provided video, the root cause is manufacturing related; however, a more specific root cause cannot be determined, and 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 EXT SET, 8", 1.6ML, NONBOND NF VALV
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931690
• Report Number: 1417592-2026-52938
• Device Sequence Number: 18541211
• Product Code: FPA
• UDI-Device Identifier: 10193489004892
• UDI-Public: 10193489004892
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093773
• 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): 09/25/2026

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: DYNDTN2001
• Device Lot Number: 0332506A216
• 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: 10/30/2025
• Initial Report FDA Received Date: 09/29/2026
• 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