MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-IV ADMIN SET, 15DRP, 3 NF PORTS, 109

Catalog Number	DYNDTN1545
Medical Device Problem Codes	Difficult to Flush (1251); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported finding no fluid flow, and the complaint transcript stated the issue did not occur during use and no injury occurred.The customer provided a photo for review; the fluid level in the drip chamber appeared to be low, and there also appeared to be a kink in the tubing beneath the drip chamber.The customer returned 1ea used device, and upon visual inspection a kink was observed in the tubing beneath the drip chamber; when the device was connected to a saline bag, primed, and unclamped, fluid flow was observed.Based on the complaint details, sample evaluation, and investigation, the complaint is not confirmed, and the documented cause was not confirmed with received sample.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.
Event or Problem Description
It was reported that 10 packs would not drip.

• Brand Name: MEDLINE
• Common Device Name: DBD-IV ADMIN SET, 15DRP, 3 NF PORTS, 109
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50910616
• Report Number: 1417592-2026-51745
• Device Sequence Number: 5778444
• Product Code: FPA
• UDI-Device Identifier: 10080196760022
• UDI-Public: 10080196760022
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 09/25/2026

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: DYNDTN1545
• Device Lot Number: 25035270
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2026
• 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: 02/25/2026
• Initial Report FDA Received Date: 09/28/2026
• 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