MEDLINE DYNDST1545Recalls & reported problems
Medline Industries, Inc. · IV ADMIN SET, 15DRP, 3 NF PORTS, 112" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884389975961), received between Apr 25, 2024 and Sep 30, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak13
- Air/Gas in Device6
- Difficult to Flush5
- Connection Problem2
- Contamination1
- Difficult to Insert1
- Excess Flow or Over-Infusion1
- Failure to Disconnect1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951339 ↗MalfunctionSep 30, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948373 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922141 ↗MalfunctionSep 28, 2026Fluid/Blood Leak; Difficult to Flush; Air/Gas in Device
It was reported that "For the IV set, we received reports about the caps being hard to remove and attach to the IV catheters. There were complaints of large air bubbles after connecting, or large amount of air bubbles, harder to flush through and leaking after connection due to them being harder to thread together."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913235 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
It was reported that "THEY HAD THE VALVES FAIL CAUSING LEAK."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898269 ↗MalfunctionSep 25, 2026Excess Flow or Over-Infusion
It was reported that "SOMETHING IS WRONG WITH THE CLAMP. THE CLAMP DOESN¿T WORK PROPERLY SO IT IS GIVING THE PATIENT TOO MANY FLUIDS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896244 ↗MalfunctionSep 24, 2026Fluid/Blood Leak; Failure to Transmit Record; Fitting Problem
It was reported that "For the IV set, we received reports about the caps being hard to remove and attach to the IV catheters. There were complaints of large air bubbles after connecting, or large amount of air bubbles, harder to flush through and leaking after connection due to them being harder to thread together."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885545 ↗MalfunctionSep 24, 2026Infusion or Flow Problem
It was reported that "The issue is that when they try to adjust the flow to 50% by using the roller nothing happens¿the fluid still drains at 100%. When the roller is adjusted the fluid drain rate is either 100% or 0. There isn¿t anything in between when you adjust the roller."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883325 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that "Our anesthesia provider is having an issue with the blue port leaking on the primary tubing (b)(6). When a secondary line is added for antibiotics, pressure is put on the bag then it pops the blue cap off the vial starts leaking."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882415 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Difficult to Flush; Air/Gas in Device
It was reported that "the caps being hard to remove and attach to the IV catheters. There were complaints of large air bubbles after connecting, or large amount of air bubbles, harder to flush through and leaking after connection due to them being harder to thread together."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867362 ↗MalfunctionSep 22, 2026Fluid/Blood Leak; Difficult to Flush; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862468 ↗MalfunctionSep 22, 2026Fluid/Blood Leak; Difficult to Insert; Connection Problem
It was reported that "when they try to connect to the catheter the tubing won't screw on and leaks."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854668 ↗MalfunctionSep 22, 2026Fluid/Blood Leak; Difficult to Flush; Air/Gas in Device
It was reported that "The caps are harder to remove and attach to the IV catheters. There have been complaints of large air bubbles after connecting, or large amount of air bubbles, harder to flush through and leaking after connection".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854583 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842975 ↗MalfunctionSep 21, 2026Failure to Disconnect
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842650 ↗MalfunctionSep 18, 2026Difficult to Flush
It was reported that the Tubing had a failure in that the Chamber would fill but again like last time, the tube would not Flush. The tube does not drip when spiked into a bag.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826211 ↗MalfunctionSep 11, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740367 ↗MalfunctionJun 1, 2026Connection Problem; Air/Gas in Device
IT WAS REPORTED THAT DURING PRIMING, AIR BUBBLES WERE CONSISTENTLY OBSERVED, INCLUDING OCCASIONAL LARGE AIR GAPS REQUIRING FLUSHING. IT WAS ALSO REPORTED THAT CONNECTING THE IV TO THE CATHETER WAS DIFFICULT AND REQUIRED INCREASED EFFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25353125 ↗MalfunctionApr 27, 2026Fluid/Blood Leak
IT WAS REPORTED ON (B)(6) THAT FLUID LEAKAGE WAS OBSERVED FROM IV ADMINISTRATION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002318 ↗MalfunctionApr 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CUSTOMER, "THE DISTAL PORT ON THE THE IV TUBING LEAKS AT TIMES."
Patient problems: Insufficient Information
MAUDE report 19181674 ↗
Other Set, administration, intravascular devices
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- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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