MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-PUMP,FEEDING,ENTERAL,ENTRAFLO RNTL

Catalog Number	ENTR99235
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the "retainer bracket was not secured in the appropriate blue holder, triggering a free flow of the isosource feed.Free flow alarm did not engage and resident received an overfeed, within her 1 hour feed time." the customer reported the resident "aspirated" as a result of the reported incident and required "emergency treatment at the hospital, but unfortunately passed away".No additional information is available at this time.It has been determined that the reported event caused or contributed to death, 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
According to the customer, the "retainer bracket was not secured in the appropriate blue holder, triggering a free flow of the isosource feed.Free flow alarm did not engage and resident received an overfeed, within her 1 hour feed time.".
Additional Manufacturer Narrative
Update to d9: device returned.Update to h3: device evaluated.Update to h6: type of investigation.Update to h6: investigation findings.Update to h6: investigation conclusions.
Additional Manufacturer Narrative
Correction to a2: age.Correction to a3a: sex.Correction to a4: weight.Correction to d4: serial number.

• Common Device Name: DBD-PUMP,FEEDING,ENTERAL,ENTRAFLO RNTL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20735818
• Report Number: 1417592-2024-00967
• Device Sequence Number: 12852595
• Product Code: LZH
• UDI-Device Identifier: 10888277420014
• UDI-Public: 10888277420014
• 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,Followup
• Report Date (Section B): 06/17/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: ENTR99235
• Device Lot Number: 96922040002
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 02/27/2025; 10/23/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 03/27/2025; 06/17/2025
• 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; Death
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 39 KG