MEDLINE DYNDTB1545Recalls & reported problems
Medline Industries, Inc. · IV ADMIN SET, 15DRP, 3 NF, 109 · Class 2
Data updated Oct 16, 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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10197344098644), received between Sep 21, 2026 and Sep 29, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Backflow” (5 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 16, 2026.
Reports received per month
Recalls naming this device
- Dec 31, 2025Open, 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
- Backflow5
- Air/Gas in Device2
- Connection Problem1
- Fluid/Blood Leak1
- Loss of or Failure to Bond1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939292 ↗MalfunctionSep 28, 2026Air/Gas in Device
It was reported that "It collapses easier at the chamber and they get more air bubbles when using the port."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914711 ↗MalfunctionSep 24, 2026Backflow
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50885960 ↗MalfunctionSep 23, 2026Backflow
It was reported that "They are having bad back flow problems".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872129 ↗MalfunctionSep 22, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859552 ↗MalfunctionSep 22, 2026Backflow
It was reported that "Fluid is backing up in the tubing."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855688 ↗MalfunctionSep 21, 2026Backflow; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848004 ↗MalfunctionSep 21, 2026Backflow; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847252 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that ¿The new version leaks a lot from the part I circled in the pic. It seems flimsy where as the old one was solid and didn¿t leak.also the DYNDTB1545 seem to be flimsier.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843147 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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