Vacuette 450096Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 19120017570346), received between Jan 8, 2020 and Feb 20, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K011786, K080235, K121908); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2020Manufacturing, Packaging or Shipping Problem

  CUSTOMER STATED THAT AFTER VENIPUNCTURE THE NURSE WAS ATTEMPTING TO ACTIVATE THE SAFETY FEATURE ON THE SBC. CUSTOMER NOTED THAT ACTIVATING THE SAFETY FEATURE REQUIRES TWO HANDS AND SQUEEZING BOTH SIDES OF THE BASE OF THE BUTTERFLY RIGHT AT THE JUNCTURE WHERE THE TUBING IS ATTACHED AND BECAUSE THERE IS BLOOD THAT REMAINS IN THE TUBING, WHEN ATTEMPTING TO SQUEEZE THE SIDES OF THE BASE OF THE BUTTERFLY, BLOOD PUSHES UP AND OUT OF THE NEEDLE FROM THE PRESSURE APPLIED AT THE BASE WHERE THE TUBING MEETS THE NEEDLE. AS THE NURSE WAS SLIDING THE SAFETY MECHANISM A DROP OF BLOOD THAT WAS COMING OUT OF THE TIP OF THE NEEDLE CAUGHT THE END OF THE SAFETY MECHANISM AND THE BLOOD FLEW OFF THE TIP AND SPLASHED IN THE NURSE'S EYE. CUSTOMER STATES DIFFICULTY IN THE PAST WITH USING THE MECHANISM BECAUSE YOU HAVE TO SQUEEZE BOTH SIDES OF THE BASE (BUTTONS) AT THE SAME TIME TO GET IT TO MOVE AND IT APPLIES PRESSURE TO THE TUBING BELOW CAUSING THE BLOOD TO MOVE UP THROUGH THE NEEDLE. CUSTOMER ADVISED THE NURSE WAS TESTED FOR EXPOSURE TO BLOOD-BORNE PATHOGENS AND NO INJURY OCCURRED / EVENT IS NOT LIFE THREATENING.

  Patient problems: Exposure to Body Fluids

  MAUDE report 9734112 ↗
• InjuryFeb 19, 2020Retraction Problem; Physical Resistance/Sticking

  CUSTOMER ADVISED THAT UPON DETERMINATION OF THE BLOOD DRAW THE PHLEBOTOMIST PLACED THE GAUZE OVER THE PUNCTURE SITE, ANCHORED IT WITH FINGER, AND ACTIVATED THE SAFETY BY PULLING BACK ON THE SAFETY MECHANISM. THE NEEDLE DID NOT FULLY RETRACT AND WAS EXPOSED STICKING THE PHLEBOTOMIST'S FINGER USED TO ANCHOR THE GAUZE. PHLEBOTOMIST COULD NOT REMEMBER IF HE HEARD/FELT THE SAFETY CLICK INTO PLACE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9727667 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATES A NEEDLESTICK OCCURED. THE PHLEBOTOMIST TRIED TO ACTIVATE THE DEVICE BY SLIDING IT BACK BUT IT STUCK, SO SHE PULLED THE NEEDLE OUT OF PATIENT THEN STUCK HER FINGER. ONE OTHER PHLEBOTOMIST MENTIONED POSSIBLE STICKY ACTIVATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9566745 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011786, K080235, K121908. One submission often covers many models, so check the product and lot details in each record.

• Z-0835-2013 · Feb 1, 2013 · Terminated
  VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipunc
• Z-0797-03 · Mar 10, 2003 · Terminated
  Vacuette, Safety Blood Collection Set with Luer Adapter