MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP

Catalog Number	DYNDTN1603
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "tubing leaking excessively.".
Additional Manufacturer Narrative
The account reported finding leaking, and the customer reported that this occurred on 3 different occurrences with the same lot number.A photo and a sample were received; the customer provided a video showing the device connected to a syringe and syringe pump with leakage occurring at the connection site between the device and the syringe, 31ea unused samples were evaluated with saline, and finished good production records were reviewed.The complaint is confirmed because leakage was observed in the video provided by the customer, although leakage was not observed during evaluation of the returned samples and no other defects were observed.The root cause is determined to be a medline labeling error, as the labeling did not indicate that the device is for gravity-use only; the device is intended for gravity-use only and is not suitable for use with pumps or pressure.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,60",2.0ML, M/F LUERLOCK,CLAMP
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869619
• Report Number: 1417592-2026-48907
• Device Sequence Number: 9314127
• Product Code: FPA
• UDI-Device Identifier: 10080196415076
• UDI-Public: 10080196415076
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/23/2026

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: DYNDTN1603
• Device Lot Number: 0332511A260
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2026
• 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: 03/20/2026
• Initial Report FDA Received Date: 09/23/2026
• 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