MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) MIC-KEY LOW PROFILE GASTROSTOMY FEEDING TUBE (G-TUBE), 16 FR., 2.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Flushing Problem (1252); Fracture (1260); Blocked Connection (2888)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  Injury  

Event Description

Needed surgical procedure, life-threatening potential, required emergency surgical procedure done as outpatient.On (b)(6) 2022 at 2200: (b)(6) (the patient) night nurse (lpn) tried to give g tube meds.When she removed the mic-key feeding port cover the small tab was noted to be fractured off.The mic-key feeding and medication port did not flush/was blocked so the lpn tried to flush harder/unplug it but it did not work despite all her efforts.She summoned me (i am parent and md) to assist but i could not get it to flush either.Possibly the cap but jammed in the feeding port but we were unable to clear it out so decided to change the g tube to a new one.Luer slip syringe was attached to the balloon valve but no return of water occurred when we aspirated nor could we insert any water in this port.The port was clean with no debris in it.We tried for hours without success.Per product manual (page 13) we used the end of large paper clip to try and depress the valve/release the water without success.We called the company medical help line without any answer.We researched the web for recommendations without success.(b)(6) went all night without vital medications/fluids/ability to emergency vent.On (b)(6) 2022.I called company in am and told our story.I was told they would have someone medical call back to help.No one ever called me.I called gi lab and spoke with on- call md that i know well.He understood this was an emergency situation as (b)(6) is g tube dependent for seizure medications/fluids, etc.He arranged an emergency endoscopy egd to be done today.(b)(6) went to (b)(6) hospital in (b)(6).She underwent upper gl endoscopy surgical procedure for retained mic-key g tube removal by dr (b)(6) md.Outpatient procedure.I have changed hundreds g tubes over the years-both professionally and personally.(b)(6) has had mic-key tubes for 25 years without a balloon problem before (changing 3-4 times a year).I did not report the (b)(6) 2022 g-tube malfunction at the time as i thought it was just a one-time issue.Reporting it now as same problem has reoccurred with another g-tube.I am concerned about a manufacturing defect.Reference report: mw5117370.

• Brand Name: MIC-KEY LOW PROFILE GASTROSTOMY FEEDING TUBE (G-TUBE), 16 FR., 2.5CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 16894583
• MDR Text Key: 314927880
• Report Number: MW5117371
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: PRN (AS NEEDED): ACETAMINOPHEN, ROBITUSSIN/OR DELSYM, BENADRYL.; TEGRETOL, BACLOFEN, REGLAN, LORATIDINE, FAMOTIDINE. ALL THESE ARE SCHEDULED MEDICATIONS. SHE HAS SEVERAL PRN (AS NEEDED) MEDS TOO. PRN MEDS: PHENERGAN, DIOSTAT, TYLENOL, DULCOLAX. MEDICAL DEVICES: STRAIGHT BLADDER CATHETERS, SUCTIONING MACHINE, KANGAROO FEEDING PUMP, PLUS SEVERAL OTHER THINGS.
• Patient Outcome(s): Other; Required Intervention; Life Threatening
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White