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

Model Number 8140-14-1.5

Device Problems Leak/Splash (1354); Defective Component (2292); Device Dislodged or Dislocated (2923); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2021

Event Type  malfunction  

Event Description

Defect or malfunction, balloon to g-tube found to have a leak.Low profile g-tube became dislodged.Balloon found to have a leak.Situation: i received a text message from the surgery resident in afternoon, that the patient¿s g-tube sutures were removed.Patient¿s mother called out that the g-tube came dislodged.Background: patient was pod2 (second post-op day) from a g-tube placement.She was scheduled to go home in the afternoon after her second bolus feed.Mom voiced she had g-tube teaching the day prior and felt comfortable going home if she tolerated her pm g-tube bolus feed.Resident texted me that the patients g-tube sutures were removed.At that time, i was with another patient.When i exited my other patient¿s room, the unit secretary told me that mom called out that her daughter¿s g-tube fell out and the charge nurse was in the room.When i got to the patient¿s room, the old g-tube was being troubleshooted.The mother instilled water in the old g-tube¿s balloon and discovered a leak.It was then that the new g-tube that was at the bedside was inserted.It was inserted with no resistance.Mother then voiced she knew what to do, and instilled 4 ml into the new g-tube balloon.A few minutes later, i notified resident that the g-tube came out and a new g-tube was reinserted.The patient was appropriately upset and was calmed with the mother¿s touch and was then given a bottle.45 minutes later, my charge nurse called me and told me she was in the room again reassuring mom¿s concerns.Vital signs were done, and charted.Once i was able to get to the patient¿s room, the patient was appropriate and stable.Mom voiced concern about the new g-tube and asked me to have the resident come assess.I texted resident about mother¿s concern and told her that the mother does not feel comfortable going home anymore.The resident replied "that¿s perfectly fine, we can reassess in the am." at this time, i no longer felt comfortable, and read through several hospital documents on g-tube dislodgment.I read that when a g-tube that is less than 6 weeks old gets dislodged, the policy is to replace it, tape it, and a fluoroscopy is needed.I called resident and voiced my concerns and explained what the policy stated.She told me she was going to talk to her attending and get back to me.I received a call from resident stating her attending agreed with ordering a fluoroscopy, and to make the patient nothing by mouth (npo).I then went into the patient¿s room and informed her of the conversation i had with both residents and explained the need for a fluoroscopy.I reached out to fluoroscopy by text message and phone call.Radiology stated their radiologist who would inject the contrast was gone for the day, and they need to figure out some logistics and would call me back.Later, a fluoroscopy tech arrived on the unit.Assessment: when i arrived at the room after the g-tube was dislodged the patient¿s assessment was stable.Her vitals on the central monitor were within normal limits.Upon reinsertion the patient remained stable.Post reinsertion the patient remained stable.My charge nurse agreed with my assessment.Recommendation: proper g-tube education needs to be done all around.The general surgery team we worked with was unaware of the needs for a fluoroscopy after a <6 week g-tube insertion dislodgment and had to reach out to their attending for clarification.If i had not double-checked documents and policies, this might have been missed.It was an emergent situation and nursing staff as well as mom did what was thought to be safest for the patient.It was a very busy day on the unit.Staffing was very short-staffed, and resources were limited.The surgery team also was very busy all day and not as easy to get ahold of.I believe with more education surrounding this topic, better staffing ratios, and better communication this issue could've been resolved better.There was no harm in this event.The lot number for the device involved in this event is unknown.

• Brand Name: AVANOS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12286854
• MDR Text Key: 265378383
• Report Number: 12286854
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8140-14-1.5
• Device Catalogue Number: 104272702
• Device Lot Number: 30107972
• 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: 07/26/2021
• Date Report to Manufacturer: 08/06/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 180 DA