MEDLINE DYNDTB1540Recalls & reported problems
Medline Industries, Inc. · IV ADMIN SET, 15DRP, SECOND, 40 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10197344098637), received between Sep 21, 2026 and Sep 30, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Dec 31, 2025Class IIOpen, Classified
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
Z-1366-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break4
- Fluid/Blood Leak2
- Connection Problem1
- Detachment of Device or Device Component1
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Fluid/Blood Leak; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952669 ↗MalfunctionSep 29, 2026Break; Material Disintegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934114 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
It was reported that "One was spiked into an acetaminophen bottle and when the tab was opened to allow in air in, it started leaking ¿ a lot. It was connected to the primary tubing that was hooked up to an IV pump."
Patient problems: Insufficient Information
MAUDE report 50915974 ↗MalfunctionSep 22, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860471 ↗MalfunctionSep 21, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847855 ↗
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 · each recall links to the FDA recall notice
- 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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