Medline DYNDTNBCS21GRecalls & reported problems
Medline Industries, Inc. · BLOOD COLLECTION SET, 21GX0.75" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10888277680227), received between Jun 28, 2024 and Sep 24, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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
- Fluid/Blood Leak4
- Insufficient Device Problem Information2
- Detachment of Device or Device Component1
- Infusion or Flow Problem1
- Material Integrity Problem1
- Physical Resistance/Sticking1
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Exposure to Body Fluids2
- 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 24, 2026Fluid/Blood Leak; Physical Resistance/Sticking
It was reported that ¿Today during a collection, the rubber cover on the vacutainer needle got stuck when inserting the tubes and blood went all over my phlebotomist and the patient.¿
Patient problems: Exposure to Body Fluids
MAUDE report 50886546 ↗MalfunctionSep 21, 2026Fluid/Blood Leak
It was reported that "My staff have reported significant issues with blood pooling into the vacutainer during blood draws and even leaking out of the vacutainer onto the blood vials resulting in blood spilling onto my staff and the patient."
Patient problems: Exposure to Body Fluids
MAUDE report 50842568 ↗MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50779642 ↗MalfunctionSep 12, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746174 ↗MalfunctionSep 11, 2026Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734764 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component; Infusion or Flow Problem
It was reported that "When the second tube was placed the mechanism was detached and suction was lost, and the tube would not fill. I then tried again and had to hold the plastic pieces around the base of the needle attached to the vacutainer to maintain the suction to fill the blood collection tube".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50692861 ↗MalfunctionSep 7, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656450 ↗MalfunctionNov 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
TODAY DURING A COLLECTION, THE RUBBER COVER ON THE VACUTAINER NEEDLE GOT STUCK WHEN INSERTING THE TUBES AND BLOOD WENT ALL OVER MY PHLEBOTOMIST AND THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20617595 ↗MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
CUSTOMER FEEDBACK: SAFETY WOULD NOT ENGAGE AFTER A BLOOD DRAW ON 5/15.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19639989 ↗
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
- 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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