Medline DYNDTNHBC21GRecalls & reported problems
Medline Industries, Inc. · BLD COLL SET, 21GX0.75", PREATTACH HLDR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10193489013115), received between Oct 18, 2024 and Sep 29, 2026 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Detachment of Device or Device Component2
- Material Integrity Problem2
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Needle Stick/Puncture2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937054 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916766 ↗MalfunctionSep 19, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831906 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
It was reported that "When employee removed the butterfly needle from the vacutainer the needle remained in the tube."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766416 ↗MalfunctionSep 11, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740986 ↗InjuryMar 19, 2025Break; Break
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 WHEN DISCONNECTING THE TUBE FROM THE BLOOD COLLECTION DEVICE THE "NEEDLE FROM THE BUTTERFLY THAT GOES INTO THE TUBES WAS STICKING OUT OF THE TOP OF THE TUBE."
Patient problems: Needle Stick/Puncture
MAUDE report 21642429 ↗InjuryFeb 18, 2025Break; Break
ACCORDING TO THE CUSTOMER, AFTER DISCONNECTING THE COLLECTION TUBE THE "NEEDLE WAS COMPLETELY GONE FROM THE HUB" REQUIRING A "RE-STICK" TO FINISH THE BLOOD COLLECTION.
Patient problems: Needle Stick/Puncture
MAUDE report 21405531 ↗MalfunctionOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE BUTTERFLY COLLECTION NEEDLE SAFETY LOCKING MECHANISM DID NOT LOCK. THE MECHANISM WOULD NOT RETRACT AND MOVE FORWARD TO COVER THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20478304 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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