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

Model Number VED-1001

Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)

Patient Problems Choking (2464); Foreign Body In Patient (2687)

Event Date 04/11/2022

Event Type  Injury  

Event Description

I am a parent to a (b)(6) special needs child/adult who is g-tube fed.While attempting to brush her teeth, her home nurse found a cap from the feeding extension lodged in the back of her throat.After carefully retrieving the cap and upon further inspection of a replacement extension, i realized the tether that is supposed to be attached to the tube had detached at some point causing the cap to become free and that allowed her to get this small cap into her mouth and choke.My conclusion was that these tethers are not strong enough.(please note) the manufacturer is also asking for this device for their own investigation, please advise on how to proceed.Fda safety report id# (b)(4).

• Brand Name: DUAL ENFIT LOW PROFILE FEEDING SET
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): VESCO MEDICAL
• MDR Report Key: 14117837
• MDR Text Key: 289466456
• Report Number: MW5109019
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 00850801006455
• UDI-Public: (01)00850801006455(17)240531(10)
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VED-1001
• Device Lot Number: H1900147
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CALCIUM 1,250 MG BID ; CETIRIZINE 10 MG ; CUVPOSA 1 MG TID ; FAMOTIDINE 40 MG BID ; GABAPENTIN 250 MG; IBUPROFEN 15 ML Q 4-6H; LEVOCARNITINE 100 MG TID; LEVOTHYROXINE 88 MKG 1/DAY ; TYLENOL 416 MG PRN Q4-6H; VALPROIC ACID 250 MG TID ; VERAPAMIL 80 MG TID; VITAMIN D 500 DAILY
• Patient Outcome(s): Life Threatening
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 27 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White