MAUDE Adverse Event Report: VESCO MEDICAL UNIVERSAL LOW PROFILE EXTENSION SET WITH ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number VED-10021

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Event Description

I use an amt mini one feeding tube with their extension sets.July 1 my dme informed me i had to switch to a generic extension produced by vesco.The first extension lasted 3 days before a small tab designed to lock the tube extension in and open a valve inside the tube for access into the stomach have experienced a failure rate of 60 percent, some the first attempt to use the tube extension.I have been using the amt mini one since 2016 and have never experienced a tab breaking off.The small tab either travels into the stomach or causes the valve to remain open and stomach contents leak out and irritate my skin.Fda safety report id (b)(4).

• Brand Name: UNIVERSAL LOW PROFILE EXTENSION SET WITH ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): VESCO MEDICAL
• MDR Report Key: 15322195
• MDR Text Key: 299044931
• Report Number: MW5111795
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 00850801006462
• UDI-Public: 01008508010064621724012210202447
• 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
• Type of Report: Initial
• Report Date: 08/26/2022

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
• Device Expiration Date: 01/22/2024
• Device Model Number: VED-10021
• Device Lot Number: 202447
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Patient Sequence Number: 1
• Treatment: IV PROTONIX, IV ZOFRAN, DAILY LACTATED RINGER'S, TUNNELED CVC CATHETER (POWERPICC SOLO), ENTERAL PEG TUBE, AMT MINI ONE FEEDING TUBE.
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White