MAUDE Adverse Event Report: VESCO MEDICAL VESCO BALLOON FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number VED220

Device Problems Loose or Intermittent Connection (1371); Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616)

Patient Problem Abdominal Pain (1685)

Event Date 01/24/2020

Event Type  Injury  

Event Description

Patient with 20f vesco balloon internal fixator feeding tube placed (b)(6) 2019 presents to er with abdominal pain, unable to tolerate enteral nutritional, seepage form en site.Er provider noted tube is in place, no action needed.Rd then saw patient with same issues, referred patient to gi who refereed patient to ir, patient without nutrition x 2 days.Upon ir assessment g tube at 10 cm (normally 2cm), balloon internal fixator had passed into the duodenum and was unable to be removed causing blockage.This thought to be due to a loose external fixator (bumper).This is the 2nd case of this happening with 2 different patients.The company has been notified, the tube was collected (ref ved220- lot 1002103 exp 06/18/2022) and was sent back to the company in a bio hazard bag.Fda safety report id # (b)(4).

• Brand Name: VESCO BALLOON FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): VESCO MEDICAL
• MDR Report Key: 9676839
• MDR Text Key: 178211609
• Report Number: MW5092795
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: VED220
• Device Lot Number: 1002103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention