MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; QUICK SWITCH VALVE, STERILE

Catalog Number	ENFIT9000S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Dobhooff connector broke.
Additional Manufacturer Narrative
It was reported that the "dobhooff connector broke and patient did not receive tube feeds for an hour." it was reported that "initially the tube feeds were leaking from enfit connector port and was slightly screwed to prevent further leaking.While on break, the break relief noticed tube feeds on the bed and floor.The port on the enfit connector".In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.Was cracked.
Additional Manufacturer Narrative
Updated d4 and h4.

• Brand Name: MEDLINE
• Common Device Name: QUICK SWITCH VALVE, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24413461
• Report Number: 1417592-2026-00135
• Device Sequence Number: 6051909
• Product Code: PIF
• UDI-Device Identifier: 10193489012569
• UDI-Public: 10193489012569
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/01/2026
• Device Catalogue Number: ENFIT9000S
• Device Lot Number: 89723030001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown