ENFit PU Feeding Tube PFTM5.0P-NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00350770001760), received between Nov 17, 2021 and Jul 29, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K082238); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074031 ↗
• MalfunctionJul 28, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054372 ↗
• MalfunctionJul 28, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054354 ↗
• MalfunctionJul 28, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054353 ↗
• MalfunctionJul 28, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054351 ↗
• MalfunctionJul 28, 2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054347 ↗
• MalfunctionJul 28, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50054344 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THE ORAL GASTRIC TUBE SNAPPED ABOUT ONE-THIRD OF THE LENGTH OF THE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25105834 ↗
• MalfunctionJan 16, 2026Material Puncture/Hole

  IT WAS REPORTED THERE WAS A HOLE IN THE NASOGASTRIC TUBE BETWEEN THE ¿CM¿ AND 5.0 FR MARKING. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097013 ↗
• InjuryNov 17, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PATIENT EXPERIENCED A STOMACH PERFORATION. ADDITIONAL INFORMATION RECEIVED 25-OCT-2021 STATED THE OG (ORAL GASTRIC) WAS INITIALLY PLACED ON (B)(6) 2021 AT 01:59AM. THE BEDSIDE RN (REGISTERED NURSE) CHARTED THE ABDOMEN WAS PINK AND DISTENDED, ON (B)(6) 2021 AT 04:00AM THE NNP (NEONATAL NURSE PRACTIONER) WAS NOTIFIED. A CXR (CHEST X-RAY) INCLUDING ABDOMEN WAS PERFORMED ON (B)(6) 2021 AT 05:30AM WHICH SHOWED PNEUMOPERITONEUM AND THE DISTAL TIP OF THE OG TUBE WAS EXTENDING BEYOND THE GASTRIC BUBBLE. A "VYGON TUBE" WAS PLACED, THE PATIENT WAS TO BE NPO (NO FEEDINGS AFTER 03:00AM) AND ZOSYN MEDICATION WAS STARTED ON (B)(6) 2021 AT 06:00AM. THE PATIENT WAS TRANSPORTED TO A CHILDREN'S MEDICAL CENTER FOR SURGICAL MANAGEMENT ON (B)(6) 2021 AT 09:10AM. THE PATIENT'S CURRENT STATUS WAS UNKNOWN AS OF 25-OCT-2021. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED ON THE STATUS ON THE PATIENT.

  Patient problems: Bowel Perforation

  MAUDE report 12828875 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082238. One submission often covers many models, so check the product and lot details in each record.

• Z-0093-2019 · Jun 4, 2018 · Terminated
  NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tu