Medline DYNDTC5077Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10080196141883), received between Mar 23, 2021 and Sep 30, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Flush

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946426 ↗
• MalfunctionSep 29, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938058 ↗
• MalfunctionSep 28, 2026Material Twisted/Bent; Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915702 ↗
• MalfunctionSep 28, 2026Explosion

  It was reported that they had a nurse who had a set "EXPLODE" and "STATED IT WAS NOT CLAMPED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914407 ↗
• MalfunctionSep 25, 2026Loose or Intermittent Connection; Detachment of Device or Device Component

  It was reported that "the tubing is thin and is easily kinked. They also stated at the tail end of the extension set has a Luer Lock that has been found to loosen with patient movement."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900140 ↗
• MalfunctionSep 25, 2026Crack

  It was reported that the entire object cracked open, including the (vinyl(?)) tube.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900093 ↗
• MalfunctionSep 25, 2026Burst Container or Vessel

  It was reported that, "while the nurse was pushing contrast thru the tubing that it ended up bursting thru the tubing, this isnt the first time it has happened."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899179 ↗
• MalfunctionSep 24, 2026Decoupling; Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889819 ↗
• MalfunctionSep 24, 2026Detachment of Device or Device Component

  It was reported that "luer lock comes off easily to an exposed end. this poses an infection and bleeding risk".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885577 ↗
• MalfunctionSep 23, 2026Melted

  It was reported that "(b)(6) Hospital is reporting multiple issues with L#127876 P#(b)(6) melting under patients. The suspicion is that the Bair Hugger is causing the tubing to melt."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867988 ↗
• MalfunctionSep 23, 2026Difficult to Flush

  It was reported that "THE PRIMING PORTION OF THE ITEM IS NOT PRIMING, LIQUID IS NOT FLOWING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867626 ↗
• MalfunctionSep 23, 2026Contamination

  It was reported that her items are defective. They are leaking, they also have brown & green stains inside tubing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50866559 ↗
• MalfunctionSep 22, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858996 ↗
• MalfunctionSep 22, 2026Difficult to Flush

  It was reported that: "We have had intermittent issues with not being able to flush. Today, 6 of the sets in a row would not flush. We tried different NS flushes, and they would not flush. The clamp was not engaged, and the luer lock was secure."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856534 ↗
• MalfunctionSep 22, 2026Disconnection; Loose or Intermittent Connection

  It was reported that "The peripheral IV lock came apart multiple times while setting up IV lines for patient and came apart while attached to a patient in the recovery room."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854941 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak; Difficult to Open or Close

  It was reported that "The iv set was fallen part, cap will not break, malfunction, 50% of them" and "-blowing the vein especially when trying to clamp or attach to IV catheter -leaking around catheter attachment -difficult to bend resulting in the tubing becoming kinked and no longer allowing fluid to flow -clave is detached or falls off when opening package."

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Vascular Problem

  MAUDE report 50852321 ↗
• MalfunctionSep 21, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842145 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak; Failure to Prime

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840070 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak; Connection Problem

  It was reported that ¿About half of this lot isn¿t tightening on appropriately and blood is dripping occasionally. They said something is seems off on the connection port.¿

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50835127 ↗
• MalfunctionSep 18, 2026Difficult to Flush

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830062 ↗
• MalfunctionSep 18, 2026Loose or Intermittent Connection; Material Deformation

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50828959 ↗
• MalfunctionJul 2, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD EXTENSION SET W/ NON BONDED NEEDLE FREE VALVE HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT¿S BEEN BROUGHT TO OUR ATTENTION OF AN ISSUE WITH THE IV EXTENSION SETS. THERE IS LEAKAGE FROM THE TUBING, THEY SEEM TO BE CRACKING WHEN SOLUTIONS RUN THROUGH THE TUBE. THE LEAK IS OCCURRING DURING THE CT PROCESS OF ADDING CONTRAST THROUGH THE IV CONNECTION. UNDER PRESSURE THE CONNECTION WILL START TO LEAK THE CONTRAST. OUR EMS STAFF RECENTLY MENTIONED THAT OCCASIONALLY THEY WILL HAVE LEAKS AT THE CONNECTION POINT. THE CT AREA IS USING A POWER INJECTOR TO CONTROL THE FLOW RATE, WHICH IS WHEN THEY SOMETIMES HAVE LEAKS. ER USES INFUSION PUMPS AND MANUAL PRESSURE. THERE ARE NO LEAKS WITH THE MANUAL PRESSURE. ALSO, ER STAFF COMMENTED THAT THE TUBING WILL SOMETIMES CRACK NEAR THE CONNECTION POINT. ON A NEW PACKAGE I OPENED, REMOVING THE CAP FOR THE CONNECTOR WAS DIFFICULT AND I THOUGHT I MAY HAVE COMPROMISED THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696488 ↗
• MalfunctionJul 2, 2026Crack

  IT WAS REPORTED THAT THE BD EXTENSION SET W/ NON BONDED NEEDLE FREE VALVE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT¿S BEEN BROUGHT TO OUR ATTENTION OF AN ISSUE WITH THE IV EXTENSION SETS. THERE IS LEAKAGE FROM THE TUBING, THEY SEEM TO BE CRACKING WHEN SOLUTIONS RUN THROUGH THE TUBE. THE LEAK IS OCCURRING DURING THE CT PROCESS OF ADDING CONTRAST THROUGH THE IV CONNECTION. UNDER PRESSURE THE CONNECTION WILL START TO LEAK THE CONTRAST. OUR EMS STAFF RECENTLY MENTIONED THAT OCCASIONALLY THEY WILL HAVE LEAKS AT THE CONNECTION POINT. THE CT AREA IS USING A POWER INJECTOR TO CONTROL THE FLOW RATE, WHICH IS WHEN THEY SOMETIMES HAVE LEAKS. ER USES INFUSION PUMPS AND MANUAL PRESSURE. THERE ARE NO LEAKS WITH THE MANUAL PRESSURE. ALSO, ER STAFF COMMENTED THAT THE TUBING WILL SOMETIMES CRACK NEAR THE CONNECTION POINT. ON A NEW PACKAGE I OPENED, REMOVING THE CAP FOR THE CONNECTOR WAS DIFFICULT AND I THOUGHT I MAY HAVE COMPROMISED THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696476 ↗
• MalfunctionJul 2, 2026Failure to Disconnect

  IT WAS REPORTED THAT THE BD EXTENSION SET W/ NON BONDED NEEDLE FREE VALVE HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT¿S BEEN BROUGHT TO OUR ATTENTION OF AN ISSUE WITH THE IV EXTENSION SETS. THERE IS LEAKAGE FROM THE TUBING, THEY SEEM TO BE CRACKING WHEN SOLUTIONS RUN THROUGH THE TUBE. THE LEAK IS OCCURRING DURING THE CT PROCESS OF ADDING CONTRAST THROUGH THE IV CONNECTION. UNDER PRESSURE THE CONNECTION WILL START TO LEAK THE CONTRAST. OUR EMS STAFF RECENTLY MENTIONED THAT OCCASIONALLY THEY WILL HAVE LEAKS AT THE CONNECTION POINT. THE CT AREA IS USING A POWER INJECTOR TO CONTROL THE FLOW RATE, WHICH IS WHEN THEY SOMETIMES HAVE LEAKS. ER USES INFUSION PUMPS AND MANUAL PRESSURE. THERE ARE NO LEAKS WITH THE MANUAL PRESSURE. ALSO, ER STAFF COMMENTED THAT THE TUBING WILL SOMETIMES CRACK NEAR THE CONNECTION POINT. ON A NEW PACKAGE I OPENED, REMOVING THE CAP FOR THE CONNECTOR WAS DIFFICULT AND I THOUGHT I MAY HAVE COMPROMISED THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696474 ↗
• MalfunctionJul 2, 2026Crack

  IT WAS REPORTED THAT THE BD EXTENSION SET W/ NON BONDED NEEDLE FREE VALVE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT¿S BEEN BROUGHT TO OUR ATTENTION OF AN ISSUE WITH THE IV EXTENSION SETS. THERE IS LEAKAGE FROM THE TUBING, THEY SEEM TO BE CRACKING WHEN SOLUTIONS RUN THROUGH THE TUBE. THE LEAK IS OCCURRING DURING THE CT PROCESS OF ADDING CONTRAST THROUGH THE IV CONNECTION. UNDER PRESSURE THE CONNECTION WILL START TO LEAK THE CONTRAST. OUR EMS STAFF RECENTLY MENTIONED THAT OCCASIONALLY THEY WILL HAVE LEAKS AT THE CONNECTION POINT. THE CT AREA IS USING A POWER INJECTOR TO CONTROL THE FLOW RATE, WHICH IS WHEN THEY SOMETIMES HAVE LEAKS. ER USES INFUSION PUMPS AND MANUAL PRESSURE. THERE ARE NO LEAKS WITH THE MANUAL PRESSURE. ALSO, ER STAFF COMMENTED THAT THE TUBING WILL SOMETIMES CRACK NEAR THE CONNECTION POINT. ON A NEW PACKAGE I OPENED, REMOVING THE CAP FOR THE CONNECTOR WAS DIFFICULT AND I THOUGHT I MAY HAVE COMPROMISED THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696473 ↗