MAUDE Adverse Event Report: AVANOS MEDICAL, INC. FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 0203121970

Device Problems Break (1069); Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)

Patient Problems Hypoglycemia (1912); No Code Available (3191)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

Date1: a small bore feeding tube was inserted at bedside (placement with cortak by trained person).The patient had high residuals and the tube feeding was on hold on and off for multiple days.Date2: nurse had advanced ng to 120 cm and requested abdominal xray.(unclear if used cortrak.) per x-ray, the tube was coiled in stomach and not yet post pyloric as ordered.Date3: continued to hold tube feedings at this time due to high residuals.Ng is gastric, unable to achieve ppft at bedside.Date4: ppft was placed in interventional radiology due to inability to place or advance at bedside.Date5: the feeding tube became clogged and was unable to clog (method to unclog tube was syringe with water (had enzymatic medication ordered but did not use).The nurse was unable to unclog the device and it was discontinued and replaced with a new oral gastric tube.Upon inspection of the discontinued feeding tube it was identified as being incomplete with the distal end of the feeding tube absent.The physician was notified.A large bore oral gastric tube was placed to continue feedings.It was assumed the distal tip of the post pyloric tube passed naturally - patient was on lactulose and stooling.No report of findings.Adverse effects: patient's blood sugar dropped to 66 with stopped feedings; 25ml d50 given and resolved hypoglycemia.Tube was in place with both liquids and crushed medications being infused.There is no sample of the tube available for evaluation.

• Brand Name: FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10161940
• MDR Text Key: 195414913
• Report Number: 10161940
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2020,06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0203121970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 123