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

Catalog Number	DYNDTN1545
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Other
Event or Problem Description
It was reported that the luer lock part that attaches the tubing to the iv catheter has been getting stuck resulting in difficulty in attaching the tubing to the iv.The luer lock part is off set from teh center resulting in it getting stuck and not threading on the iv catheter easily.
Additional Manufacturer Narrative
The customer reported that the luer lock part that attaches the tubing to the iv catheter has been getting stuck, resulting in difficulty in attaching the tubing to the iv, and that the luer lock part is off set from the center resulting in it getting stuck and not threading on the iv catheter easily.Medline quality received 3 ea for evaluation, and functional inspection was conducted with the provided samples; it was found that the item function normally, no issues have been found.At this time, the reported concern could not be confirmed, as the item function normally; the suspected root cause is undetermined at this time.A retrospective review of the past two years for this product indicated that there have been no prior complaints in regard to this issue, and the division will continue to monitor this issue for any additional 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: 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: 50896922
• Report Number: 1417592-2026-50776
• Device Sequence Number: 20290841
• Product Code: FPA
• UDI-Device Identifier: 20080196760029
• UDI-Public: 20080196760029
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Catalogue Number: DYNDTN1545
• Device Lot Number: 24015262
• 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: 07/10/2024
• Initial Report FDA Received Date: 09/25/2026
• 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