IV Administration Set 354210Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04046964182174), received between Nov 23, 2016 and Nov 12, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0654-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Leak/Splash; Leak/Splash

  AS REPORTED VIA MEDWATCH NUMBER MW5177238. DESCRIBE EVENT OR PROBLEM: THE FIRST SECTION OF THE ANESTHESIA IV SET TUBING AFTER THE PORTION THAT ATTACHES TO THE PATIENT DISCONNECTED AND BLOODY IV FLUID SPILLED ONTO THE EXPOSED FOOT OF THE NURSE CARING FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531728 ↗
• MalfunctionFeb 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 1: AS REPORTED BY THE USER FACILITY: THE DEVICE DISCONNECTED DURING USE, CAUSING LEAKAGE OF BLOOD AND MEDICATION (NORMAL SALINE, LACTATED RINGERS, AND PROPOFOL). THE DEVICE LEAKED BETWEEN THE PRIMARY LINE AND EXTENSION SET, AND AT THE DISTAL END OF THE EXTENSION SET. DUE TO LEAKAGE ONTO THE FLOOR, A CLINICIAN SLIPPED AND FELL.

  Patient problems: Fall

  MAUDE report 11302111 ↗
• MalfunctionFeb 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  EVENT 2: AS REPORTED BY THE USER FACILITY: THE DEVICE DISCONNECTED DURING USE, CAUSING LEAKAGE OF BLOOD AND MEDICATION (NORMAL SALINE, LACTATED RINGERS, AND PROPOFOL). THE DEVICE LEAKED BETWEEN THE PRIMARY LINE AND EXTENSION SET, AND AT THE DISTAL END OF THE EXTENSION SET. DUE TO LEAKAGE ONTO THE FLOOR, A CLINICIAN SLIPPED AND FELL.

  Patient problems: Fall

  MAUDE report 11302080 ↗
• MalfunctionJan 13, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A HAIR WAS SEEN INSIDE THE IV SET. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580663 ↗
• MalfunctionDec 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE ANESTHESIA IS HAVING AN ISSUE WITH THE LOWER CONNECTION. THE CONNECTION IS CONSTANTLY VERY LOOSE IN THE PACKAGING AND NURSES HAVE TO TIGHTEN THE CONNECTION. THEY ARE NOT SURE IF ANESTHESIA IS TIGHTENING THE CONNECTION WHEN THEY SET UP THE TUBING. THE TUBING BECAME DISCONNECTED FROM THE PATIENT CAUSING BLOOD TO LEAK ALL OVER THE FLOOR. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9457804 ↗
• MalfunctionSep 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DESPITE THE NURSES TIGHTENING AND CHECKING CONNECTIONS PRIOR TO PATIENTS GOING TO THE OR, THE CONNECTIONS BECOME LOOSE CAUSING BLOOD OR IV FLUIDS TO SPILL. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112724 ↗
• MalfunctionJul 23, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: END USER REPORTS: THAT THE SET DISCONNECTED, CAUSING PATIENT'S BLOOD TO LEAKED. THE PATIENT'S IV SET DISCONTINUED DURING SURGERY AND THE PATIENT WOKE UP COVERED WITH BLOOD AFTER SURGERY.

  Patient problems: Blood Loss

  MAUDE report 7711971 ↗
• MalfunctionJun 1, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING SURGERY, THE TUBING DISCONNECTED AND BLOOD LEAKED ONTO THE FLOOR. END USER REPORTS NO INJURY TO PATIENT, AS THE SET WAS RECONNECTED ONCE DISCONNECTION WAS NOTICED.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7561989 ↗
• MalfunctionApr 6, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY USER FACILITY: THEY HAD A DISTAL IV DISCONNECTION DURING SURGERY. THIS WAS NOTICED AFTER BLOOD LEAKAGE NOTED ON THE FLOOR. MULTIPLE ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION AND NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. UNKNOWN IF ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6463479 ↗
• MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY USER FACILITY: REPORTS WHEN PATIENT CAME OUT OF SURGERY THERE WAS BLOOD EVERYWHERE IN THE BED. BLOOD HAD BACKED UP THE LINE AND WAS LEAKING OUT FROM ABOVE THE LOWER Y-SITE. IT WAS UNCERTAIN OF THE LENGTH OF TIME THAT THE SET HAD COME APART. SET SEPARATED ABOVE THE DISTAL Y-SITE CONNECTOR. EVERYTHING BELOW THE Y-SITE IS INTACT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6124411 ↗