Self-Cath 50443 / 310Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932999878), received between Jul 6, 2016 and Jul 6, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2016Break

  ACCORDING TO THE AVAILABLE INFORMATION, CUSTOMER STATED THAT THE CATHETER WAS DIFFICULT TO INSERT AND SHE NOTICED THAT THE TIP WAS BROKEN OFF. SHE USED A CATHETER AND WENT TO REUSE IT A FEW HOURS LATER. IT WOULDN'T GO IN PROPERLY. SHE LOOKED AT IT AND REALIZED THE SMOOTH END HAD BROKEN OFF. SHE DOES NOT THINK IT BROKE WHILE CATHING. END USER STATED THAT THERE WAS NO DISCOMFORT AT THE TIME OF THE INITIAL CATHETERIZATION EPISODE. SHE STATED THAT SHE FOUND IT DIFFICULT TO INSERT THE CATHETER AFTER CLEANING IT FOR REUSE AND THAT WAS WHEN SHE DISCOVERED THE MISSING TIP. IT DID NOT APPEAR TO BE NOTICED DURING THE CLEANING PROCESS. THERE WAS NO PHYSICAL HARM OR INJURY. SHE DID CONSULT WITH HER PHYSICIAN AND WAS GIVEN A RENAL ULTRASOUND TO INVESTIGATE IF THE MISSING TIP WAS IN THE URINARY TRACT. THE RESULTS OF THE ULTRASOUND WERE NEGATIVE. THERE IS NO PORTION OF THE CATHETER INSIDE HER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5773466 ↗