MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV ADMIN SET, 15DRP, 3 NF PORTS, 112"

Catalog Number	DYNDST1545
Medical Device Problem Codes	Fluid/Blood Leak (1250); Failure to Transmit Record (1521); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "for the iv set, we received reports about the caps being hard to remove and attach to the iv catheters.There were complaints of large air bubbles after connecting, or large amount of air bubbles, harder to flush through and leaking after connection due to them being harder to thread together.".
Additional Manufacturer Narrative
The account reported caps being hard to remove and attach to the iv catheters, large air bubbles after connecting, harder to flush through, and leaking after connection due to them being harder to thread together.A sample was received for investigation; 5 samples were randomly selected and tested by attaching the iv admin set to a saline iv bag and priming the sample before allowing fluid to flow through for 10 minutes, and the manufacturer reviewed production records and retained samples.For all samples evaluated, the issues reported by the customer were not observed, and the manufacturer did not find any discrepancies or defects in the production records or retained samples that could have contributed or caused the reported issue.Based on the complaint details, sample evaluation, and investigation, the complaint is not confirmed, 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 ADMIN SET, 15DRP, 3 NF PORTS, 112"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50885545
• Report Number: 1417592-2026-50200
• Device Sequence Number: 15900545
• Product Code: FPA
• UDI-Device Identifier: 10884389975961
• UDI-Public: 10884389975961
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: DYNDST1545
• Device Lot Number: 0332410A050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/05/2025
• 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: 10/09/2025
• Initial Report FDA Received Date: 09/24/2026
• 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