MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	ENFIT70552
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medline, entraflow does not flow after priming.Chamber fills and will not drip.The staff tried trouble-shooting by manually filling and clearing the system.It continues to beep and displays "occlusion".Manufacturer response for tubes, gastrointestinal (and accessories), medline industries (per site reporter) will obtain.

• Brand Name: MEDLINE INDUSTRIES
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 16723954
• Report Number: 16723954
• Device Sequence Number: 18130141
• Product Code: KNT
• UDI-Device Identifier: 10884389190333
• UDI-Public: (01)10884389190333(17)20250228(10)96922030001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/29/2023
• Report Date (Section F): 03/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: ENFIT70552
• Device Catalogue Number: ENFIT70552
• Device Lot Number: 96922030001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 04/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/29/2023