Vacuette 450161Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 19120049202413), received between Feb 21, 2020 and Feb 21, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2020Use of Device Problem

  CUSTOMER IS REPORTING A NEEDLE STICK. PHLEBOTOMIST THOUGHT THE SAFETY DEVICE WAS ACTIVATED AFTER THE STICK. WHEN GATHERING SUPPLIES HE FELT THE SHARP. THE NEEDLE SLID HAD OUT OF THE PROTECTION SHEATH AND STUCK HIS HAND. CUSTOMER STATED THEY DO NOT BELIEVE THIS WAS A USER ERROR. CUSTOMER ADVISED THEY PLACE REFERENCE ITEMS IN STOCK BINS PRIOR TO USE AND THE BINS CAN CONTAIN MULTIPLE LOT NUMBERS. CUSTOMER STATES THEY HAVE SEVERAL LOTS IN USE AND CANNOT IDENTIFY WHICH LOT WAS ASSOCIATED WITH THE INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9740862 ↗
• InjuryFeb 21, 2020Break; Mechanical Problem; Material Separation

  CUSTOMER STATES THEY EXPERIENCED A NEEDLE STICK INJURY WHEN THE NEEDLE WAS BEING WITHDRAWN FROM PATIENT'S HAND. WHILE THE PHLEBOTOMIST WAS TERMINATING THE VENIPUNCTURE AND ACTIVATING THE SAFETY, THE PATIENT MOVED AND THE NEEDLE CAUGHT THE PHLEBOTOMIST NEAR THE THUMB. CUSTOMER ADVISED THAT WHILE ACTIVATING THE SAFETY, THE PHLEBOTOMIST WAS NOT ABLE TO ANCHOR THE DEVICE AT THE WING DUE TO THE DRAW SITE BEING ON THE HAND. NO ISSUES WITH THE DEVICE REPORTED. CUSTOMER ADVISED OF AN INCIDENT WHERE THE NEEDLE/WING SECTION SEPARATED FROM THE REMAINDER OF THE DEVICE WHILE THE PHLEBOTOMIST ACTIVATED THE SAFETY MECHANISM. THE PHLEBOTOMIST PUSHED THE BUTTONS ON THE HUB TO ACTIVATE THE SAFETY AND WHILE PULLING BACK THE SAFETY MECHANISM, IT KEPT GOING AND BROKE AWAY FROM NEEDLE. CUSTOMER ADVISED THAT THE DEVICE WAS SAVED. CUSTOMER ADVISED THAT THE CONNECTOR TO THE LUER NEEDLE SEPARATED FROM THE LUER/HOLDER RESULTING IN A BLOOD EXPOSURE. THE PHLEBOTOMIST PUSHED THE BLOOD COLLECTION TUBE ON, THE TUBE PUSHED BACK AND WHEN THE PHLEBOTOMIST PUSHED THE TUBE BACK ON, THE CONNECTOR DISCONNECTED FROM THE LUER/HOLDER. CUSTOMER ADVISED THAT THE DEVICE WAS NOT SAVED. CUSTOMER ADVISED OF ANOTHER BLOOD EXPOSUR

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 9739213 ↗

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