MAUDE Adverse Event Report: EXTENSION FEEDING SET DUAL ENFIT PORT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

The dme company for my 8 month old baby recently switched over to enfit style enteral feeding supplies.When we used the mckesson extension feeding set dual enfit port 12 in the first time the connected caps that screw in for the to cover the feeding port and medicine port come detached.My son had it on for 5 minutes for before he had the tube in his mouth and it detached in his mouth.Very concerning as a chocking hazard and there are no other options since the old style will no longer be produced.Fda safety report id# (b)(4).

• Brand Name: EXTENSION FEEDING SET DUAL ENFIT PORT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• MDR Report Key: 15380834
• MDR Text Key: 299770981
• Report Number: MW5111939
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/03/2022

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Patient Sequence Number: 1
• Treatment: ALBUTEROL.; ERYTHROMYCIN.; FEEDING PUMP.; GLYCOPYRROLATE.; NEBULIZER.; OMEPRAZOLE.; OXYGEN CONCENTRATOR.; PULMICORT.; PULSE OXIMETER.; SUCTION MACHINE.; TRIAMCINOLONE OINTMENT.; VITAMIN D.
• Patient Age: 8 MO
• Patient Sex: Male
• Patient Weight: 9 KG
• Patient Ethnicity: Hispanic
• Patient Race: White