Navarre NBD10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741036842), received between Feb 28, 2018 and May 15, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT FEW DAYS POST DRAINAGE CATHETER PLACEMENT PROCEDURE, THE CATHETER HUB WAS ALLEGEDLY FOUND BROKE. IT WAS FURTHER REPORTED THAT THE BROKEN HUB WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403849 ↗
• MalfunctionMay 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING DRAINAGE CATHETER PLACEMENT PROCEDURE, THE CATHETER HUB ALLEGEDLY FOUND LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403829 ↗
• MalfunctionMar 16, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOME TIME POST DRAINAGE CATHETER PLACEMENT FOR ABDOMINAL DRAINAGE, THE CATHETER HUB ALLEGEDLY CRACKED WHICH RESULTED IN LEAKAGE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13788781 ↗
• MalfunctionApr 22, 2020Component Missing; Component Missing

  IT WAS REPORTED UPON OPENING THE DRAINAGE CATHETER KIT, THE STRING ON THE CATHETER WAS ALLEGEDLY FOUND MISSING. REPORTEDLY, A NEW KIT WAS OPENED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9986187 ↗
• MalfunctionSep 27, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CHRONIC CATHETER PLACEMENT, THE CHRONIC CATHETER WAS ALLEGEDLY UNABLE TO LOAD TO THE GUIDEWIRE DUE TO DAMAGED TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131784 ↗
• MalfunctionSep 27, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING CHRONIC CATHETER PLACEMENT, THE CHRONIC CATHETER WAS ALLEGEDLY UNABLE TO LOAD TO THE GUIDEWIRE DUE TO DAMAGED TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131607 ↗
• MalfunctionFeb 20, 2019Crack; Crack

  IT WAS REPORTED THAT POST DRAINAGE TUBE EXCHANGE, THE PATIENT'S CAREGIVER FOUND THAT THE HUB OF THE TUBE HAD ALLEGEDLY CRACKED WHICH HAD CAUSED LEAKING. IT WAS FURTHER REPORTED THAT THE DRAINAGE TUBE WAS EXCHANGED AGAIN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8356554 ↗
• MalfunctionFeb 28, 2018Crack

  IT WAS REPORTED THAT THE RN CALLED THE SALES REP TO REPORT A CRACKED DRAINAGE CATHETER, ALLEGEDLY THE HUB WAS CRACKED. NO FURTHER DETAILS WERE GIVEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304292 ↗