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

Catalog Number	DYNDST1512
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the nurse anesthetists are complaining about the injection ports failing." the customer further reported, "the failure is with the anti-reflux port located most distal, blood has spilled out of the port on several occasions as well as the iv fluid dripping from the same port, thus issues with maintaining sterility are concern as well.".
Additional Manufacturer Narrative
The customer reported that the ports were failing and that the medication used is propofol with lidocaine; the failure is with the anti-reflux port located most distal, with blood spilled out of the port on several occasions as well as iv fluid dripping from the same port.Medline received 3 boxes of iv administration set, randomly selected 15 samples for testing, hooked all samples up to an iv administration bag, observed for leaking or the reported issue of the anti-reflux port failing, and checked all connections thoroughly.This was not observed in any case, and the complaint was not confirmed.Investigation included review of recent complaint trends, objectionable trends were not seen for this issue, and division has been informed and will continue to monitor trends.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: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867223
• Report Number: 1417592-2026-48557
• Device Sequence Number: 9425871
• Product Code: FPA
• UDI-Device Identifier: 20884389975951
• UDI-Public: 20884389975951
• 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): 09/22/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/08/2023
• 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: 04/28/2023
• 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