MAUDE Adverse Event Report: VESCO MEDICAL, LLC VESCO MEDICAL EXTENSION FEEDING SET; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

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

Event Type  Other  

Event Description

This company is a feeding tube extension manufacturer.The only company in the nation who makes them.Yet they have two caps that can easily be torn off and placed into their mouth.My daughter is 23 years old and is developmentally a newborn, spastic quad cerebral palsy.Her cerebral palsy mainly affects her right limbs, her dominant hand is left but despite every effort we have made, she has managed three times to tear a cap off and choke on it.This most recent occasion it was lodged in her throat for 10 days.This device is going to kill someone, if that hasn't happened already.

• Brand Name: VESCO MEDICAL EXTENSION FEEDING SET
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): VESCO MEDICAL, LLC
• MDR Report Key: 17745078
• MDR Text Key: 323480496
• Report Number: MW5145607
• 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: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1