BD Vacutainer® Safety-Lok™ Blood Collection Set 367294Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 30382903672944), received between Jan 28, 2019 and Jul 15, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER NOTICED THE HOLDER WAS COMING LOOSE FROM THE NON-PATIENT NEEDLE AND THE SLEEVE DID NOT COVER THE NEEDLE AFTER DISCONNECTING THE TUBE FROM THE ADAPTER ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506919 ↗
• MalfunctionMay 20, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT WHILE USING 295 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER NOTICED THE BLOOD FLOW WAS VERY SLOW, CAUSING THE SAMPLES TO COAGULATE OR NOT TO REACH AN OPTIMAL CAPACITY. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055733 ↗
• MalfunctionMay 19, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, CUSTOMER NOTICED THE VACUUM WAS VERY SLOW, CAUSING THE SAMPLES TO COAGULATE OR NOT TO REACH AN OPTIMAL CAPACITY. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044619 ↗
• MalfunctionFeb 6, 2025Coagulation in Device or Device Ingredient; Short Fill; Coagulation in Device or Device Ingredient; Short Fill

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER EXPERIENCED SLOW FLOW WHEN CONNECTING THE TUBES TO THE VACUUM, CAUSING THE SAMPLES TO COAGULATE OR NOT TO REACH AN OPTIMUM CAPACITY ON UNSPECIFIED NUMBER OF DEVICES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21321711 ↗
• MalfunctionJan 3, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE CUSTOMER OBSERVE THAT THE HOSE IS FILLED BUT THE BLOOD FALLS VERY SLOWLY INTO THE TUBE CAUSING THE SAMPLE IS HEMOLYZED. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074058 ↗
• MalfunctionDec 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET EXPERIENCED BLOOD LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: BLOOD LEAKAGE INSIDE THE COLLECTION ADAPTOR (CUSTOMER USES TUBES FROM GREINER AND BD'S PERFORATION DEVICES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12918009 ↗
• MalfunctionDec 16, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO USE THE SLEEVE FALLS OFF WITH A BD WINGSET SLBCS 25X.75 7LUER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED BY CUSTOMER PLASTIC SLEEVE COVERING NEEDLE CAME OFF BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 9475585 ↗
• MalfunctionJan 28, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT A BD VACUTAINER® SAFETY-LOK BLOOD COLLECTION SET WAS MISSING LUER ADAPTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283541 ↗