MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ENTRAFLO ENTERAL FD 1L BG GRAV ADMIN SET

Catalog Number	ENFIT70503
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a gravity feed bag was connected to a patient's nasogastric (ng) tube, and feeding began.Shortly after, a leak was noticed in the tubing.While the nurse was assessing the situation and attempting to disconnect the tubing, the connection broke, leaving the female attachment of the bag stuck in the male attachment of the ng tube.This prevented the ng cap from being screwed back on to clamp the port.As a result, the nurse had to remove the ng tube and insert a new one.It has been determined that medical intervention was required, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Leak in the tubing and broken connection.
Additional Manufacturer Narrative
A sample was returned and investigated.

• Common Device Name: ENTRAFLO ENTERAL FD 1L BG GRAV ADMIN SET
• 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: 20162095
• Report Number: 1417592-2024-00843
• Device Sequence Number: 7363435
• Product Code: PIF
• UDI-Device Identifier: 40884389190327
• UDI-Public: 40884389190327
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/13/2025

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?: No
• Device Catalogue Number: ENFIT70503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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