MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD ENTRAFLO FEEDING PUMP SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 96923050003

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

The entraflo 1000ml feeding pump set was in use and suddenly started to alarm.The nurse went in and found that the tubing had come apart where the spin dial turns causing free flowing of tube feeding in the floor.Entraflo feeding pump set.Medline lot 96923050003.

• Brand Name: ENTRAFLO FEEDING PUMP SET
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 18335027
• MDR Text Key: 330714314
• Report Number: MW5149278
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2023

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
• Device Operator: Health Professional
• Device Lot Number: 96923050003
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American