Connector 456080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964183669), received between Nov 16, 2023 and Nov 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: NKARTA HAS OBSERVED PARTICLES DURING THE CELL THERAPY MANUFACTURING PROCESS. A CRITICAL INVESTIGATION HAS BEEN INITIATED TO FURTHER DETERMINE ROOT CAUSE OF THE PARTICULATES AND TO POTENTIALLY IDENTIFY THE SOURCE(S). A THIRD PARTY ANALYSIS WAS PERFORMED ON PARTICULATE SAMPLES AND CHARACTERIZATION OF PARTICLES INCLUDE: PET POLYESTER. CELLULOSE; COLORED (YELLOW, TAN, BLUE) AND COLORLESS. NYLON. NKARTA HAS IDENTIFIED VENDORS THAT PROVIDE MATERIALS UPSTREAM OF THE MANUFACTURING PROCESS INCIDENT THAT MAY HAVE CONTRIBUTED TO THE PARTICULATES FOUND. ADDITIONAL INFORMATION PROVIDED: THE PARTICLE WAS ISOLATED IN OUR MANUFACTURING PROCESS. WE CANNOT DETERMINE IF THE PARTICLE ORIGINATED FROM THE FLUID PATH OR NON-FLUID PATH OF THE DOUBLE MALE LUER. WE IDENTIFIED THE DOUBLE MALE LUER AS A COMPONENT THAT WAS USED UPSTREAM BEFORE THE PARTICLE WAS ISOLATED. HENCE, WHY WE SENT A SUPPLIER QUESTIONNAIRE RELATED TO MATERIAL OF CONTRUCTION (MOC) OF THE DOUBLE MALE LUER TO SEE IF THE PARTICLE MAY HAVE ORIGINATED FROM THE DOUBLE MALE LUER ITSELF. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151877 ↗