MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV ADMIN SET, 15DR, FLOW CNTRL, 1INJECT

Catalog Number	DYNDTN1522H
Medical Device Problem Codes	Compatibility Problem (2960); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the iv administration tubing that was sent to me through medline with the drip chamber and flow controller did not work with an infusion.There was no flow happening despite all troubleshooting efforts.".
Additional Manufacturer Narrative
The customer reported that the iv administration tubing with the drip chamber and flow controller did not work with an infusion and that there was no flow happening despite all troubleshooting efforts; customer stated they have only used 2 ea out of the 15 ea order and both have had the same issue.At this time, a sample(s) was not received for investigation; investigation included review of recent complaint trends, and objectionable trends were not seen for this issue.The complaint was not confirmed.Without the sample or photo, it is difficult to truly identify the root use of the issue; 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, 15DR, FLOW CNTRL, 1INJECT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50883197
• Report Number: 1417592-2026-49794
• Device Sequence Number: 18808361
• Product Code: FPA
• UDI-Device Identifier: 10888277403048
• UDI-Public: 10888277403048
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: DYNDTN1522H
• 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: 06/08/2023
• Initial Report FDA Received Date: 09/24/2026
• 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