Argyle 8888160325 (UDI 20884527005106)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884527005106), received between Aug 1, 2017 and Mar 5, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT AN UMBILICAL CATHETER THAT WAS REMOVED FROM A PATIENT AFTER A FEW DAYS USE BECAUSE THE CONNECTION WOULD NOT STAY SECURELY ATTACHED TO THE IV FLUID LINES. PER CUSTOMER, THE TEETH WERE WORN DOWN OR CHIPPED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CONNECTION HUB HAS TWO TEETH AND CAUSED CONNECTION ISSUE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528448 ↗
• MalfunctionOct 27, 2022Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE SR. WAS ATTEMPTING TO FLUSH THE CATHETER, BUT THE CATHETER SEEMED TO BE BLOCKED. THEY WERE UNABLE TO USE SAID CATHETER. THE CATHETER WAS NOT INSERTED, THEY FOUND THE BLOCKAGE BEFORE IT WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678759 ↗
• MalfunctionAug 1, 2017Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTS THAT THE CATHETER SLOT CRACKED AND LEAKED DURING ONGOING THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6757987 ↗