ENFit PVC Feeding Tube PFTM6.5V-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770001876), received between Jan 17, 2023 and Jan 17, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED 27JAN2023 REPORTED, THE PRETERM INFANT WAS DELIVERED BY CESAREAN SECTION DUE TO HELLP SYNDROME (HEMOLYSIS WITH A MICROANGIOPATHIC BLOOD SMEAR, ELEVATED LIVER ENZYMES, AND A LOW PLATELET COUNT). APGAR SCORES 9 AND 9 AND 1 AND 5 MINUTES, RESPECTIVELY. AN OROGASTRIC TUBE WAS PLACED ON ADMISSION, IT WAS LATER CHANGED TO A NASOGASTRIC TUBE; INITIAL FEEDINGS CONSISTED OF BREAST MILK AND LATER BREAST MILK FORTIFIED WITH LIQUID HUMAN MILK. SELECTED DIAGNOSES AND TREATMENTS IN NICU: RESPIRATORY DISTRESS SYNDROME TREATED WITH SUPPLEMENTAL O2 AND CONTINUOUS POSITIVE AIRWAY PRESSURE. APNEA OF PREMATURITY NOT REQUIRING CAFFEINE . HYPERBILIRUBINEMIA REQUIRING MONITORING BUT NOT PHOTOTHERAPY . BLOODY STOOLS. ON DAY OF LIFE (DOL) 6, THE INFANT HAD A SMALL AMOUNT OF BLOOD IN THE STOOL WITH OTHERWISE NORMAL EXAM. EXAM, RADIOGRAPHS AND LABORATORY STUDIES WERE NORMAL, LIQUID HUMAN MILK FORTIFIERS (HMF) REMOVED FROM FEEDINGS. ON DOL 11, THE INFANT HAD GREATLY INCREASED AMOUNTS OF BLOOD IN THE STOOL REPEAT KIDNEY URETHRA AND BLADDER (KUB) EXAMS WERE EQUIVOCAL, FEEDINGS WERE STOPPED, AND THE INFANT RECEIVED ANTIBIOTICS FOR 7 DAYS WHICH WERE SUBSEQUENTLY SUCCESSFULLY; THE I

  Patient problems: Apnea; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Hyperbilirubinemia; Respiratory Distress Syndrome of Newborns

  MAUDE report 16187636 ↗
• InjuryJan 17, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2023-00004 FOR THE SECOND REPORT. IT WAS REPORTED, THE INFANT HAD GASTROINTESTINAL (GI) BLEEDING FOR WHICH NO CLEAR CAUSE WAS ESTABLISHED. NO MEDICAL INTERVENTION WAS REPORTED. THE INFANT¿S CURRENT CONDITION WAS NOT REPORTED.

  Patient problems: Apnea; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Hyperbilirubinemia; Respiratory Distress Syndrome of Newborns

  MAUDE report 16187607 ↗