MEDLINE DYNDTB5081Recalls & reported problems
Medline Industries, Inc. · IV EXT SET,SMBORE EXT,8,M LUERLOCK,1NF · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10197344098668), received between Dec 9, 2025 and Sep 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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
- Fluid/Blood Leak2
- Connection Problem1
- Disconnection1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Disconnection; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903711 ↗MalfunctionSep 23, 2026Fluid/Blood Leak; Connection Problem
It was reported that "fluid is leaking out of the tubing at distal tip where the small tubing connects to the next piece." It was also reported that "The part where they connect the saline flush syringe is difficult to screw the syringe on and they have to really pry to get it on there."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867940 ↗MalfunctionDec 9, 2025Leak/Splash; Leak/Splash
MEDICATION DRIPPED OUT OF THE EXTENSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23757191 ↗
Other Set, administration, intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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