MAUDE Adverse Event Report: KENTEC ENFIT TUBE FEEDING 5FT 40CM

Catalog Number ENF-Y5OP

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Code Available (3191)

Event Date 06/21/2017

Event Type  Injury  

Event Description

Pa 5fr ameritus enfit ng tube was inserted on a pt.The package labeling stated the tube was radiopaque.The tube did not show up on x-ray.An 8fr ameritus enfit ng tube was inserted on the same pt.The package also stated it was radiopaque.That tube did not show up on x-ray either.Resulted in several unnecessary x-rays to patient.Products in question: kentec catalog #enf-y50p-40.

• Brand Name: ENFIT TUBE FEEDING 5FT 40CM
• Type of Device: ENFIT TUBE FEEDING
• Manufacturer (Section D): KENTEC
• MDR Report Key: 6666597
• MDR Text Key: 78471359
• Report Number: MW5070603
• Device Sequence Number: 1
• Product Code: LZH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENF-Y5OP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention