MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; IV EXT SET, 6.5", 0.7ML, NONBOND NF

Catalog Number	DYNDTC5077
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "(b)(6) hospital is reporting multiple issues with l#127876 p#(b)(6) melting under patients.The suspicion is that the bair hugger is causing the tubing to melt.".
Additional Manufacturer Narrative
The customer reported that the items were melting under patients and that the suspicion is that the bair hugger is causing the tubing to melt.The customer did not provide the sample nor the picture for evaluation, and despite multiple good faith efforts to obtain additional information, no additional details were available related to the customer reported issue.At this time, the reported concern could not be confirmed, as medline was not able to investigate the issue.No root cause was identified, and if additional relevant information becomes available this report will be reopened and reevaluated.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 EXT SET, 6.5", 0.7ML, NONBOND NF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867988
• Report Number: 1417592-2026-48660
• Device Sequence Number: 15808813
• Product Code: FPA
• UDI-Device Identifier: 40080196141884
• UDI-Public: 40080196141884
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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: DYNDTC5077
• Device Lot Number: 127876
• Was Device Available for Evaluation?: No
• 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: 02/13/2024
• Initial Report FDA Received Date: 09/23/2026
• 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