MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) MIC-KEY GASTROSTOMY G-TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Burst Container or Vessel (1074); Product Quality Problem (1506); Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Hemorrhage/Bleeding (1888); Fluid Discharge (2686)

Event Date 01/04/2023

Event Type  malfunction  

Event Description

Mic-key tube 12 fr.1.2 cm was noted to be out of stoma upon first assessment.The balloon was burst upon assessment of it.Mild bleeding and drainage at site.Nnp provider notified and said they called surgery this is in addition to previous burst g tube incidents- a second nicu incident yesterday ((b)(6) 2023), another incident (b)(6) 2022 in pediatric icu and one (b)(6) 2022 in hku (an acute care unit).In (b)(6) 2022 this organization had experienced 20 mic-key ruptures the prior year and after being repeatedly reporting to the manufacturer they acknowledged a manufacturing defect and changed our stock out.The company opted not to issue a recall.Later ruptures in 2022 resulted in avanos stating our organization had somehow mistakenly received the faulty stock again on re-stock.Since that time we have experienced the same concerns at intervals including the issue reported here, burst tubes result in patients needing to undergo additional anesthesia and have the tubes replaced surgically.This was actually the 6th incident since mid-december all were same tube model mic-key gastrostomy feeding tube 12fr but in different cm sizes.See other relevant history.Reference reports: mw5114277, mw5114279, and mw5114280.

• Brand Name: MIC-KEY GASTROSTOMY G-TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 16147665
• MDR Text Key: 307223142
• Report Number: MW5114278
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 MO
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Ethnicity: Hispanic