Medline DYNDTN1512Recalls & reported problems
Medline Industries, Inc. · IV ADMIN SET, 15DRP, 2 NF PORTS, 96" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10080196760091), received between May 24, 2024 and Sep 29, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (6 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
- Material Twisted/Bent6
- Defective Component2
- Complete Blockage1
- Fluid/Blood Leak1
- Infusion or Flow Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Complete Blockage; Material Twisted/Bent
It was reported that "tubing sealed at the opening and fluid is unable to go though the tubing".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935172 ↗MalfunctionSep 29, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934170 ↗MalfunctionSep 24, 2026Material Twisted/Bent
It was reported that IV GRAVITY SET TUBING KINKED BELOW DRIP CHAMBER AND ANOTHER IV GRAVITY SET TUBING SEALED BELOW CHECK VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883676 ↗MalfunctionSep 23, 2026Material Twisted/Bent
It was reported that GRAVITY SET TUBING KINKED AND CLOSED UNDER DRIP CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872191 ↗MalfunctionSep 23, 2026Material Deformation; Material Twisted/Bent
It was reported that IV GRAVITY SET TUBING KINKED AND CLOSED UNDER DRIP CHAMBER X4 SETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870180 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841515 ↗MalfunctionSep 20, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834747 ↗MalfunctionMar 31, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD GRAVITY SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THEY HAD A KINK IN TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735839 ↗MalfunctionMar 31, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD GRAVITY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. ¿TUBING SEALED AT THE OPENING AND FLUID IS UNABLE TO GO THROUGH THE TUBING.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735744 ↗MalfunctionMay 24, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD IV GRAVITY SET WAS KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE FOLLOWING IV GRAVITY SETS HAVE KINKS IN THE LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19392107 ↗
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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
- 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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