MAUDE Adverse Event Report: HALYARD ENFIT 20; TUBE, FEEDING

Model Number REF 8100-22-22F

Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Injury (2348)

Event Date 12/11/2018

Event Type  Injury  

Event Description

We encountered a tube (enfit 20f) that was delivered with the bumper on the tube upside down.Unfortunately the placement team did not catch this and placed the tube causing stoma site harm to the pt.We reported this internally for our own reviews.

• Brand Name: ENFIT 20
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): HALYARD; alpharetta GA 30005
• MDR Report Key: 8186268
• MDR Text Key: 131376339
• Report Number: MW5082361
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/25/2018
• Device Model Number: REF 8100-22-22F
• Device Lot Number: AA8176D17
• Was Device Available for Evaluation?: No
• 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): Life Threatening