MEDLINE DYNDTN2001Recalls & reported problems
Medline Industries, Inc. · IV EXT SET, 8", 1.6ML, NONBOND NF VALV · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489004892), received between Feb 11, 2026 and Sep 29, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Crack” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack3
- Fluid/Blood Leak2
- Break1
- Detachment of Device or Device Component1
- Leak/Splash1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fluid/Blood Leak; Detachment of Device or Device Component
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50933816 ↗MalfunctionSep 29, 2026Crack; Material Puncture/Hole
It was reported that "Customer was using item and it was squirting fluid out of the port site. Appears to have crack or hole in port."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931690 ↗MalfunctionJun 5, 2026Break
THE THE FEMALE LUER LOCK DISCONNECTS VERY EASILY FROM THE PART THAT CONNECTS TO THE SYRINGE/TUBING. MORE CONCERNING, HOWEVER, IS THAT WHILE A PATIENT WAS RECEIVING IV FLUIDS, THE PLASTIC TUBING THAT CONNECTS TO THE LUER LOCK SEEMINGLY BROKE OFF. THERE SHOULD BE NO LOOSE ATTACHMENT AT THIS SPOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417273 ↗MalfunctionFeb 17, 2026Crack; Leak/Splash
ACCORDING TO THE FACILITY "J LOOP HAS CRACKS AND IS DEFECTIVE AND LEAKED ALL OVER THE CUSTOMERS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369936 ↗MalfunctionFeb 11, 2026Crack; Fluid/Blood Leak
ACCORDING TO THE FACILITY, "J LOOP HAS CRACKS AND IS DEFECTIVE AND LEAKED ALL OVER THE CUSTOMERS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317667 ↗
Other Set, administration, intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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