MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-ENFIT G-TUBE CONNECTOR,MEDLINE

Catalog Number	ENFIT1010GC
Medical Device Problem Codes	Failure to Disconnect (2541); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "part of the connector becomes detached and the harder plastic part is almost impossible to detach from the patient's tube.".
Additional Manufacturer Narrative
The customer reported three separate occurrences with three different patients and three different nurses where part of the connector becomes detached and the harder plastic part is almost impossible to detach from the patient's tube; no injury was reported.No physical or photo samples of the complaint item or issue were provided by the customer for review, limiting the ability to investigate the issue thoroughly, and analysis of complaint data determined there were 5 other complaints with this item regarding this issue.Based on the information provided and the results of the investigation, medline was not able to confirm the reported issue or that the product failed to meet specifications; the cause was unconfirmed because a sample was required to determine cause.A review of the complaint information as well as the results of the investigation indicated no need for further action, and complaints are monitored via the trend analysis procedure.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-ENFIT G-TUBE CONNECTOR,MEDLINE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870293
• Report Number: 1417592-2026-49044
• Device Sequence Number: 10743183
• Product Code: PIO
• UDI-Device Identifier: 10888277314719
• UDI-Public: 10888277314719
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151628
• 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: ENFIT1010GC
• 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: 10/14/2025
• 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