MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PUMP,FEEDING,ENTERAL,ENTRAFLO,PURCHASE

Catalog Number	ENT199235
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, the "pump was set to deliver 480cc over 2 hours and a total of 480cc was put in the bag.After the dose limit of 480cc was reached there was still approximately 70cc left in the bag, the total 480cc wasn't delivered to the patient." the customer reports there was no medical intervention or treatment required for the patient.No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Event or Problem Description
According to the facility, the "pump was set to deliver 480cc over 2 hours and a total of 480cc was put in the bag.After the dose limit of 480cc was reached there was still approximately 70cc left in the bag, the total 480cc wasn't delivered to the patient." the customer reports there was no medical intervention or treatment required for the patient.

• Brand Name: MEDLINE
• Common Device Name: PUMP,FEEDING,ENTERAL,ENTRAFLO,PURCHASE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24491538
• Report Number: 1417592-2026-00170
• Device Sequence Number: 12035045
• Product Code: LZH
• UDI-Device Identifier: 10888277420045
• UDI-Public: 10888277420045
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K891575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: ENT199235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 03/02/2026
• 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