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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.