Navarre NNU12PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741036941), received between May 26, 2023 and May 26, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Fluid/Blood Leak; Fracture; Air/Gas in Device; Fluid/Blood Leak; Fracture; Air/Gas in Device

  IT WAS REPORTED THAT APPROXIMATELY ONE DAY AFTER THE CATHETER PLACEMENT PROCEDURE, AIR WAS ALLEGEDLY ENTERED WHEN THE FLUSHED FLUID WAS ASPIRATED BACK INTO THE SYRINGE. IT WAS FURTHER REPORTED THAT THE WHITE PLASTIC HUB WAS ALLEGEDLY CRACKED, AND THE FLUID DRAINING FROM THE PATIENT'S BODY CAVITY LEAKED EXTERNALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009147 ↗
• MalfunctionMay 26, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE WHITE PLASTIC HUB WAS ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED ONCE CRACKED, THE FLUID DRAINING FROM THE PATIENT'S BODY CAVITY LEAKED EXTERNALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009073 ↗
• MalfunctionMay 26, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING CHRONIC CATHETER PLACEMENT PROCEDURE, THE WHITE PLASTIC HUB WAS ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED ONCE CRACKED THE FLUID DRAINING FROM THE PATIENT'S BODY CAVITY LEAKS EXTERNALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008726 ↗
• MalfunctionMay 26, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING CHRONIC CATHETER PLACEMENT PROCEDURE, THE WHITE PLASTIC HUB WAS ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED ONCE CRACKED THE FLUID DRAINING FROM THE PATIENT'S BODY CAVITY LEAKS EXTERNALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008703 ↗