MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV ADMIN SET, 15DRP, 2 NF PORTS, 108"

Catalog Number	DYNDST1512
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blue nozzle to the left always leaking liquid when in use.
Additional Manufacturer Narrative
The customer/reporter described issues of the blue nozzle to the left always leaking liquid when in use.Medline quality received the item for evaluation; three samples were randomly selected to perform a visual inspection and functional test, including attaching a training iv bag filled with fluids before attaching the iv set to a catheter and letting the fluids run through the line as the dose rate was adjusted to different settings.The visual inspection revealed no manufacturing defects preventing the samples to work as intended, functional testing experienced no leakage, and the reported concern could not be confirmed, as the items function normally and no abnormalities have been found.The cause was not confirmed with received sample, and the division will continue to monitor this issue for trending.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 ADMIN SET, 15DRP, 2 NF PORTS, 108"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50841636
• Report Number: 1417592-2026-46387
• Device Sequence Number: 10263309
• Product Code: FPA
• UDI-Device Identifier: 20884389975951
• UDI-Public: 20884389975951
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/18/2026

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: DYNDST1512
• Device Lot Number: 0332307A012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/09/2023
• 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: 10/19/2023
• Initial Report FDA Received Date: 09/21/2026
• 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