MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SET,PUMP,1000ML BAG,ENFIT,MEDLINE

Catalog Number	ENFIT70552
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the issue is with the enfit portion, enfit twist connector" and "the enfit piece has been shattering causing pieces to be stuck in the end of the extension tubing or just leaking.".
Additional Manufacturer Narrative
It was reported that ¿there is an issue with the enfit portion of the enfit twist connector; the enfit piece has been shattering causing pieces to be stuck in the end of the extension tubing or just causing the item to leak.¿ 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: SET,PUMP,1000ML BAG,ENFIT,MEDLINE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: durga duduku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946757
• Report Number: 1417592-2026-54329
• Device Sequence Number: 9499633
• Product Code: PIF
• UDI-Device Identifier: 10884389190333
• UDI-Public: 10884389190333
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150286
• 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): 09/29/2026

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: ENFIT70552
• Device Lot Number: 96925010001
• 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: 10/27/2025
• Initial Report FDA Received Date: 09/30/2026
• 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