BD Vacutainer® Safety-Lok™ Blood Collection Set 367298Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903672982), received between May 9, 2018 and Sep 21, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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.

• InjurySep 21, 2020Product Quality Problem; Difficult or Delayed Activation; Product Quality Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THERE WAS A RETRACTION ISSUE WHICH LED TO NEEDLESTICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS AN ACCIDENTAL NEEDLE STICK INJURY DUE TO THE NEEDLE NOT FULLY RETRACTING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10561004 ↗
• MalfunctionJun 4, 2018Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET HAD A CLOGGING PROBLEM. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7564776 ↗
• MalfunctionMay 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SETS HAD MIXED PRODUCT IN THE PACKAGING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500753 ↗