Medline DYNDTNHBC23GRecalls & reported problems
Medline Industries, Inc. · BLD COLL SET, 23GX0.75", PREATTACH HLDR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10193489013122), received between Jun 24, 2024 and Sep 30, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component3
- Break2
- Dull, Blunt2
- Fluid/Blood Leak2
- Decoupling1
- Disconnection1
- Insufficient Device Problem Information1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Hemorrhage/Blood Loss/Bleeding1
- Needle Stick/Puncture1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952497 ↗MalfunctionSep 30, 2026Decoupling
It was reported that Tip of Onguard Wing-Tip Device suppurated from collect syringe post collection.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945716 ↗MalfunctionSep 23, 2026Dull, Blunt
SF Phlebotomy Supervisor showed me some of our Medline On-Guard Blood Collection Sets that have an issue the Needle is NOT beveled, just blunted
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872151 ↗MalfunctionSep 23, 2026Dull, Blunt
SF Phlebotomy Supervisor showed me some of our Medline On-Guard Blood Collection Sets that have an issue the Needle is NOT beveled, just blunted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872149 ↗MalfunctionSep 16, 2026Detachment of Device or Device Component
It was reported that "Tubing is also detaching from the needle."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786359 ↗MalfunctionSep 14, 2026Break; Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that "We had a Medline Butterfly Device needle (the needle in the hub), come out of the hub today (on (b)(6) 2024) and blood began running into the patient¿s lap. It looks like the plastic on the threaded part of the hub broke."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50758779 ↗MalfunctionSep 10, 2026Protective Measures Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50722748 ↗MalfunctionSep 10, 2026Fluid/Blood Leak; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719107 ↗MalfunctionSep 10, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718527 ↗MalfunctionSep 10, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715234 ↗MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
LVN REPORTS THAT 3 TIMES IN THE LAST MONTH WHILE USING THE MEDLINE ONGUARD BLOOD COLLECTION SET, AS THEY ARE SQUEEZING THE DEVICE TO ENGAGE THE SAFETY IT BREAKS OFF FROM THE TUBING. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19592105 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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