MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ENFIT EXT. SET, 12", RIGHT ANGLE, YPORT

Catalog Number	ENFIT12RAY
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the junction for the mickey button, is breaking.Causing pieces of plastic to be left in the mickey tube.This has occurred 4 times, that she is aware of.".
Additional Manufacturer Narrative
The customer reported the junction for the mickey button is breaking, causing pieces of plastic to be left in the mickey tube, and this has occurred 4 times.The sample was not available for evaluation; however one photo was provided by the customer, and review of the photo showed the connector fractured at the junction, with a portion of the plastic collar broken off and separated from the main component.Based on the information provided, the reported issue was confirmed.The vendor conducted an internal investigation, and a review of the production process, associated records, and retained samples did not identify any abnormalities or defects; the root cause of the issue was not able to be determined, and no further action was indicated at this time.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: ENFIT EXT. SET, 12", RIGHT ANGLE, YPORT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897575
• Report Number: 1417592-2026-50868
• Device Sequence Number: 18812519
• Product Code: KNT
• UDI-Device Identifier: 10888277629004
• UDI-Public: 10888277629004
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141631
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ENFIT12RAY
• Device Lot Number: H2300010
• 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: 02/10/2026
• Initial Report FDA Received Date: 09/25/2026
• 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