MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD MIC* JEJUNAL FEEDING TUBE WITH ENFIT CONNECTOR, 12 FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 44566

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 11/20/2019

Event Type  malfunction  

Event Description

Patient had a jejunostomy tube (j-tube) requiring cardizem medication to be instilled.At 0026, tube feeding machine was paused, what appeared to be "port" of tube feeding line had 20ml water flushed through, and half of crushed cardizem med in water was administered.Line began to get sluggish and then a pop sound occurred.At this point patient complained of sharp pain.Doctor and charge nurse were notified.Doctor said to turn off tube feeding for the time being, and attempt instilling second half of cardizem medication at 0200.At 0200, the cardizem medication again would not go into the j-tube, and with just about 3ml of content administered the patient again complained of sharp pain, so i stopped all med administration.I asked for a second opinion on the patient's status and notified the crisis nurse.We changed the wound dressing at the site.Nurse assessment and mine also warranted notifying the doctor using the "i am concerned" statements, and doctor came to the bedside to also see how the patient was doing.The patient's belly looked slightly rounded at the site.He was diaphoretic and had been all night, including now.Respirations were on the high end as was heartrate.Doctor put in an order for ct and for a transfer to another floor.After the ct was completed downstairs, the crisis nurse notified me that the j-tube had dislodged downstairs.She showed me that what i had believed was a port for med administration may have actually been the balloon to keep the j-tube stable.I was educated on the whole mechanism of the j-tube tubing and securement.

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9686473
• MDR Text Key: 178335495
• Report Number: 9686473
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44566
• Device Catalogue Number: 8200-12LV
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2020
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25915 DA