IV Administration Set V1390Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04046964188176), received between Jan 16, 2020 and Jul 6, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2: PER CUSTOMER REPORT: "WHEN I HOOK THE ADMIN SETS UP TO THE IV BAG THE LINES ARE GETTING AIR INTO THEM AND SO I'VE EITHER HAD TO DRAIN A LOT OF THE FLUID OFF BEFORE INSERTION OR I'VE NOTICED ONCE I'VE STARTED THE IV AND SO HAVE HAD TO STOP THE DRIP, UNHOOK THE BAG, TAKE OUT THE NEEDLE AND DRAIN THE BAG AND THEN HOPE I CAN GET ANOTHER VEIN, ALL OF WHICH IS TERRIBLY UNCOMFORTABLE AND ANNOYING FOR THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935520 ↗
• MalfunctionJul 6, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1: PER CUSTOMER REPORT: "WHEN I HOOK THE ADMIN SETS UP TO THE IV BAG THE LINES ARE GETTING AIR INTO THEM AND SO I'VE EITHER HAD TO DRAIN A LOT OF THE FLUID OFF BEFORE INSERTION OR I'VE NOTICED ONCE I'VE STARTED THE IV AND SO HAVE HAD TO STOP THE DRIP, UNHOOK THE BAG, TAKE OUT THE NEEDLE AND DRAIN THE BAG AND THEN HOPE I CAN GET ANOTHER VEIN, ALL OF WHICH IS TERRIBLY UNCOMFORTABLE AND ANNOYING FOR THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935498 ↗
• MalfunctionJul 6, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 4: PER CUSTOMER REPORT: "WHEN I HOOK THE ADMIN SETS UP TO THE IV BAG THE LINES ARE GETTING AIR INTO THEM AND SO I'VE EITHER HAD TO DRAIN A LOT OF THE FLUID OFF BEFORE INSERTION OR I'VE NOTICED ONCE I'VE STARTED THE IV AND SO HAVE HAD TO STOP THE DRIP, UNHOOK THE BAG, TAKE OUT THE NEEDLE AND DRAIN THE BAG AND THEN HOPE I CAN GET ANOTHER VEIN, ALL OF WHICH IS TERRIBLY UNCOMFORTABLE AND ANNOYING FOR THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935496 ↗
• MalfunctionJul 6, 2022Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 3: PER CUSTOMER REPORT: "WHEN I HOOK THE ADMIN SETS UP TO THE IV BAG THE LINES ARE GETTING AIR INTO THEM AND SO I'VE EITHER HAD TO DRAIN A LOT OF THE FLUID OFF BEFORE INSERTION OR I'VE NOTICED ONCE I'VE STARTED THE IV AND SO HAVE HAD TO STOP THE DRIP, UNHOOK THE BAG, TAKE OUT THE NEEDLE AND DRAIN THE BAG AND THEN HOPE I CAN GET ANOTHER VEIN, ALL OF WHICH IS TERRIBLY UNCOMFORTABLE AND ANNOYING FOR THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14935487 ↗
• MalfunctionNov 23, 2021Inaccurate Flow Rate; Air/Gas in Device; Inaccurate Flow Rate; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): PLASTIC TUBING NOT AS FLEXIBLE AS IT ONCE WAS AND THE FLOW RATE IS NOT AS ACCURATE WITH THE DIAL. THEY SAID THERE ARE MANY AIR BUBBLES THAT THEY SEE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862329 ↗
• MalfunctionOct 21, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY: "WE JUST OPENED A BOX OF THE V1390 IV ADMINISTRATION SET, BY B. BRAUN, LENGTH 83" (210CM), PRIMING VOLUME: 15ML AND NOTICED THAT IT SEEMS DIFFERENT THAN USUAL. THE TUBING IS STIFFER AND THE ROLLER CLAMP IS VERY STIFF AND DOES NOT GIVE A LOT OF OPTIONS FOR DRIP SPEED. IT IS EITHER FAST OR VERY SLOW, NOT LIKE BEFORE WHERE YOU COULD STOP IT ANYWHERE ALONG THE CHANNEL TO GIVE YOU THE SPEED OF DRIP YOU NEED. THE ROLLER IS ALSO STIFF AND SHARP AND NOT EASY TO MANIPULATE LIKE BEFORE. IT ACTUALLY HURTS YOUR THUMB WHEN YOU ROLL IT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12671054 ↗
• MalfunctionOct 19, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE IV LINES ARE STIFF AND THE ROLLERS DO NOT OPEN AND CLOSE PROPERLY. NONE OF THE DOCTORS FEEL COMFORTABLE USING THE PRODUCT AS YOU CANNOT PROPERLY SET A DRIP RATE AND CLINIC DOES NOT HAVE IV PUMPS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657167 ↗
• MalfunctionOct 19, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT ROLLER CLAMP MARKS AFFECTED THE FLOW OF MEDICATION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657151 ↗
• MalfunctionSep 2, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: RN REPORTS THAT "THE TUBING IS STIFFER AND STICKIER, MAKING IT CUMBERSOME TO HANDLE AT TIMES. THE ROLLER CLAMP IS NOW MADE OF A HARDER/SHARPER PLASTIC AND THE ROLLER IS MORE DIFFICULT TO ROLL UP AND DOWN, WHICH MAKES IT BOTH PAINFUL AND INACCURATE WHEN CALCULATING THE DRIP RATE. THE ROLLER CLAMP HAS LITERALLY SENT SHOCKING PAIN UP MY THUMB, WHICH HAS NEVER HAPPENED WITH PREVIOUS CLAMPS, AND IT IS EITHER ALL THE WAY OPEN OR EXTREMELY SLOW IN MANY CASES." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419051 ↗
• MalfunctionAug 16, 2021Free or Unrestricted Flow; Free or Unrestricted Flow

  AS REPORTED BY THE USER FACILITY: END USER REPORTS THAT THE TUBING IS STIFFER, THOUGH IT ISN'T AS BIG OF A DEAL AS THE ROLLER CLAMP. THE ROLLER CLAMP IS MADE OF HARDER/SHARPER PLASTIC AND THE ROLLER IS MORE DIFFICULT TO ROLL UP AND DOWN, WHICH MAKES IT PAINFUL AND THE DRIP RATE IS NOT AS ACCURATE. NO INJURY REPORTED.

  Patient problems: Pain

  MAUDE report 12323883 ↗
• MalfunctionJul 13, 2021Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILITY: "CLAMP MAKES IT DIFFICULT TO REGULATE THE FLOW OF FLUID AND ONCE SET AND WE LEAVE AND RETURN, WE FIND OUR INFUSION RATES HAVE CHANGED (FASTER THAN IT WAS SET FOR)." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12157458 ↗
• MalfunctionJan 16, 2020Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILLITY: IT WAS REPORTED THAT THE BAGS ARE NOT EMPTYING COMPLETELY AND AIR IS PUSHING INTO THE PATIENTS. WE HAD QUITE A FEW PATIENTS SAYING THAT THERE WAS AIR LEFT IN THE BAG AND LINE ITSELF. NO INJURY REPORTED.

  Patient problems: Dyspnea

  MAUDE report 9595932 ↗
• MalfunctionJan 16, 2020Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILLITY: IT WAS REPORTED THAT THE BAGS ARE NOT EMPTYING COMPLETELY AND AIR IS PUSHING INTO THE PATIENTS. WE HAD QUITE A FEW PATIENTS SAYING THAT THERE WAS AIR LEFT IN THE BAG AND LINE ITSELF. NO INJURY REPORTED.

  Patient problems: Dyspnea

  MAUDE report 9595925 ↗
• MalfunctionJan 16, 2020Improper Flow or Infusion; Improper Flow or Infusion

  AS REPORTED BY THE USER FACILLITY: IT WAS REPORTED THAT THE BAGS ARE NOT EMPTYING COMPLETELY AND AIR IS PUSHING INTO THE PATIENTS. WE HAD QUITE A FEW PATIENTS SAYING THAT THERE WAS AIR LEFT IN THE BAG AND LINE ITSELF. NO INJURY REPORTED.

  Patient problems: Dyspnea

  MAUDE report 9595922 ↗