AVANOS 42772Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets with ENFit® Connector · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770427720), received between Mar 28, 2024 and Mar 28, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Bacterial Infection1
- Burning Sensation1
- Fungal Infection1
- Hemorrhage/Blood Loss/Bleeding1
- Itching Sensation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED "THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] WAS PLACED FEBRUARY 15TH; THE TUBE HAD A NOTABLE SMALL LEAKAGE FROM THE PORT FROM DAY ONE HOWEVER THE LEAKAGE BECAME MORE PRONOUNCED WITH USE OF THE EXTENSION SET. CONFIRMED LEAKAGE FROM THE TUBE, UPON DISCONTINUATION OF A FEEDING THE TUBE WILL SLOW LEAK FROM THE PORT. STOMA CONFIRMED DRY AND NOT INVOLVED BY SATURATION WITH POWDER, THE POWDER WAS DRY BUT THE PADS WERE WET ON THE OUTER SIDE SHOWING THAT THE PORT OF THE G-TUBE HAD LEAKED... ON MARCH 1ST ITCHING BURNING AND BLEEDING WAS NOTED... ON MARCH 4 AN IMMEDIATE CARE VISIT WAS MADE... ON MARCH 7TH DERMATOLOGY CONFIRMED THAT THERE WAS A YEAST AND PROBABLE GRAM-POSITIVE BACTERIAL INFECTION." THE PATIENT DEVELOPED FUNGAL AND BACTERIAL INFECTION DUE TO EXPOSURE TO STOMACH ACIDS. "TREATMENT FOR THE PATIENT ENTAILED OUTPATIENT DERMATOLOGY / IMMEDIATE CARE CENTER, DIAGNOSES: INFECTION OF A STOMA - GASTROSTOMY - STOMATITIS - BACTERIAL, INFECTION OF A STOMA - GASTROSTOMY - STOMATITIS - FUNGAL (CANDIDA ALBICANS). TREATMENT RENDERED INCLUDED TOPICAL ANTIFUNGAL, ORAL ANTIFUNGAL, MONITORING, TOPICAL ANTIBIOTIC, CHANGE OF PEG TUBE AFTER MAJORITY OF INFECTION WAS CLEARED."
Patient problems: Bacterial Infection; Burning Sensation; Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Itching Sensation
MAUDE report 18997243 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.