Medline DYNDTC5081Recalls & reported problems
Medline Industries, Inc. · IV EXT SET, 8", 0.3ML, NONBOND NF VALVE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10080196141913), received between May 1, 2023 and Sep 30, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Difficult to Flush” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Flush3
- Leak/Splash2
- Complete Blockage1
- Contamination1
- Crack1
- Detachment of Device or Device Component1
- Difficult to Open or Close1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Jam
It was reported that "THE MALE LUER LOCK ADAPTER ON IT STICKS OR BONDS, UNABLE TO BREAK IT LOSE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947178 ↗MalfunctionSep 28, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923270 ↗MalfunctionSep 25, 2026Difficult to Flush
It was reported that "For about the last 2 weeks we have been having an increasing number of extension sets difficult to flush or not working at all. Currently about ever other set if not every set has to be disassembled to get the needle free valve to work."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898700 ↗MalfunctionSep 25, 2026Difficult to Flush
It was reported that, ¿When we have to push saline or meds, sometimes it does not allow you to. We have to disconnect and reconnect several times before we can do IV push. The problem seems to be in the stopper of these IV extenders.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898435 ↗MalfunctionSep 24, 2026Difficult to Flush
It was reported that "unable to flush the extension set, almost like they are clogged with something."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889073 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
It was reported that "One of the valves falls apart easily."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854653 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported that "It doesn't work the blood/solution just pours through it onto the ground."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853336 ↗MalfunctionSep 21, 2026Crack
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50841948 ↗MalfunctionSep 21, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838644 ↗MalfunctionAug 10, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD IV EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT CRACK DURING INFUSION. PLASTIC PIECE AT END THAT CONNECTS TO IV TUBING IS CRACKING DURING INFUSION, BLOOD GOES EVERYWHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22767885 ↗MalfunctionJun 30, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT CRACKED PLASTIC PIECE. PLASTIC PIECE AT END THAT CONNECTS TO IV TUBING IS CRACKING DURING INFUSION, BLOOD GOES EVERYWHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22367799 ↗MalfunctionApr 22, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT; TUBE SEALED A/ BLOCKED AT OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887077 ↗MalfunctionMay 1, 2023Contamination; Contamination
IT WAS REPORTED THAT THE BD EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS WAS FOUND DISCOLORED FROM YELLOW TO BROWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCOLORATION FROM YELLOW TO BROWN".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16847748 ↗
Other Set, administration, intravascular devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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