Medline DYNDTNBCS23GRecalls & reported problems
Medline Industries, Inc. · BLOOD COLLECTION SET, 23GX0.75" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10888277680234), received between Apr 14, 2024 and Sep 30, 2026 — classified as 3 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 Component8
- Insufficient Device Problem Information7
- Fluid/Blood Leak5
- Appropriate Device Problem Term/Code Not Available3
- Air/Gas in Device2
- Material Integrity Problem2
- Retraction Problem2
- Accessory Incompatible1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Needle Stick/Puncture5
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948270 ↗MalfunctionSep 23, 2026Fluid/Blood Leak
It was reported that Blood running out of the tube holder in excessive amounts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870885 ↗MalfunctionSep 23, 2026Retraction Problem
It was reported that "some of our Phlebs have had issue with the needle retracting as they are inserting it into the patients arm."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869675 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component; Air/Gas in Device
Patient problems: Needle Stick/Puncture
MAUDE report 50822597 ↗MalfunctionSep 18, 2026Retraction Problem
Patient problems: Needle Stick/Puncture
MAUDE report 50820982 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810334 ↗MalfunctionSep 16, 2026Accessory Incompatible; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795014 ↗MalfunctionSep 16, 2026Disconnection; Detachment of Device or Device Component
It was reported that "Two butterflies became disconnected while drawing a patient, the disconnect was with the blood tube not patient entrance site."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793463 ↗MalfunctionSep 16, 2026Gas/Air Leak; Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50786451 ↗MalfunctionSep 14, 2026Detachment of Device or Device Component; Activation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763845 ↗MalfunctionSep 14, 2026Crack; Fluid/Blood Leak
It was reported that "Butterfly needle is failing and leaking blood at the hub connection site. There appears to be small cracks in the plastic."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755652 ↗MalfunctionSep 12, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746361 ↗MalfunctionSep 11, 2026Dull, Blunt; Material Twisted/Bent
It was reported that "needle is not sharp, some needles bending, some needles possibly having imperfections on the tip."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734022 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733560 ↗MalfunctionSep 10, 2026Material Separation; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723213 ↗MalfunctionSep 10, 2026Fluid/Blood Leak; Detachment of Device or Device Component
It was reported that "Somewhere in the tubing line was a hole. Once we stuck the patient and started getting blood return, it started pouring out of the tubing."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718531 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717528 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716371 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715529 ↗MalfunctionDec 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
COMPLAINT DETAILS: TWO BUTTERFLIES BECAME DISCONNECTED WHILE DRAWING A PATIENT, THE DISCONNECT WAS WITH THE BLOOD TUBE NOT PATIENT ENTRANCE SITE. DEFECTIVE PRODUCT IS STILL AVAILABLE ONSITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20815721 ↗MalfunctionOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
EXCESS BUBBLES IN THE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20478308 ↗MalfunctionOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
COMPLAINTS ARE NEEDLE IS NOT SHARP, SOME NEEDLES BENDING, SOME NEEDLES POSSIBLY HAVING IMPERFECTIONS ON THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20478305 ↗MalfunctionSep 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
BUTTERFLY NEEDLE IS FAILING AND LEAKING BLOOD AT THE HUB CONNECTION SITE. THERE APPEARS TO BE SMALL CRACKS IN THE PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20330499 ↗MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE PROBLEM REPORTED TO ME WAS MULTIPLE NURSES WHEN DRAWING PATIENT'S BLOOD WERE GETTING FLASH BACK, AND THE BLOOD WAS NOT COMING ALL THE WAY DOWN INTO THE TUBE. IF YOU HAVE ANY QUESTIONS AND WOULD LIKE TO SPEAK TO A NURSE - I WOULD SUGGEST SPEAKING WITH SARAH HAMPTON, RN WHO WAS THE FIRST TO REPORT THE ISSUE. HER CONTACT # IS 314-830-8879 (WORK PH).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19592107 ↗MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
WHILE THE PHLEBOTOMIST ENGAGED THE SAFETY THE NEEDLE CAME OUT OF THE BUTTERFLY AND WAS STUCK IN THE PATIENT'S ARM. PRIOR TO THIS WE NOTED AIR IN THE LINE. A FEW PATIENTS BEFORE THIS ALSO NOTED AIR IN THE LINE, BUT THE NEEDLE DID NOT DISCHARGE FROM THE BUTTERFLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19592074 ↗
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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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