BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder 368654Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30382903686545), received between Jan 17, 2024 and Aug 11, 2026 — classified as 1 injury, 20 malfunctions.

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

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213119 ↗
• MalfunctionMar 30, 2026Premature Separation

  IT WAS REPORTED PRIOR TO USINGBD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE NEEDLE CAP WAS MISSING AND THE NEEDLE POINT PIERCED THROUGH THE PACKAGING LEADING TO A NEEDLESTICK. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718877 ↗
• MalfunctionMar 17, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, BLOOD DOES NOT FLOW INTO THE TUBE. THIS OCCURRED AN UNSPECIFIED NUMBER OF TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621374 ↗
• MalfunctionFeb 23, 2026Short Fill

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, INSUFFICIENT BLOOD FLOWS THROUGH ONE DEVICE AS A RESULT OF A HOOKED NEEDLE USED DURING BLOOD DRAW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421648 ↗
• MalfunctionDec 16, 2025Difficult or Delayed Activation; Packaging Problem; Difficult or Delayed Activation; Packaging Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WAS 10 DEVICES THAT HAD AN OPEN SEAL AND AN UNSPECIFIED NUMBER OF NEEDLES HAD SAFETY SHIELD ISSUES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822254 ↗
• MalfunctionDec 10, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED AFTER USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE THE HEALTHCARE PROVIDER HAD DIFFICULTY ACTIVATING THE SAFETY COVER IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771017 ↗
• InjuryDec 10, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED AFTER USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE THE HEALTHCARE PROVIDER HAD DIFFICULTY ACTIVATING THE SAFETY COVER IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23771014 ↗
• MalfunctionDec 1, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER; 3 DEVICES HAD OPEN PACKAGING AND WERE NOT SEALED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688420 ↗
• MalfunctionJul 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USING TWO BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE CUSTOMER FOUND VISIBLE PARTICLES OR FOREIGN MATTER INSIDE THE STERILE PACKAGED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382657 ↗
• MalfunctionMar 27, 2025Leak/Splash; Short Fill; Leak/Splash; Short Fill

  IT WAS REPORTED THAT WHILE USING ONE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE CUSTOMER NOTICED BLOOD LEAKAGE AT THE BASE OF THE NEEDLE AND AIR IN THE TUBING. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707821 ↗
• MalfunctionJan 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, BLOOD CONTINUES TO FLOW FROM THE NON-PATIENT NEEDLE WHEN THE TUBE WAS REMOVED. NO PATIENT IMPACT REPORTED, HOWEVER BLOOD GOT ON THE NURSE'S GLOVES, SHOES, THE ARMREST OF THE CHAIR AND ON THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210332 ↗
• MalfunctionJan 8, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING THREE (3) BD VACUTAINER® SAFETY-LOK¿ BLOOD, THE NEEDLE SEPARATED; IT CAME OUT OF THE PATIENT'S SKIN. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108476 ↗
• MalfunctionDec 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, WHEN THE TUBE WAS PUNCTURED, BLOOD WENT BACK UP INTO THE SAMPLING BODY EXPOSING THE PATIENT TO THE RISK OF CONTACT DURING TREATMENT. NO OTHER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924586 ↗
• MalfunctionDec 11, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING ONE (1) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, WHEN THE TUBE WAS PUNCTURED, BLOOD WENT BACK UP INTO THE SAMPLING BODY EXPOSING THE PATIENT TO THE RISK OF CONTACT DURING TREATMENT. NO OTHER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905225 ↗
• MalfunctionNov 27, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT BEFORE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE CUSTOMER NOTICED 12 UNITS HAVE BEEN FOLDED IN BETWEEN THE PLASTIC, TEARING THE STERILE SEALED PAPER. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791783 ↗
• MalfunctionNov 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WERE PARTICLES AND FOREIGN BODIES OBSERVED IN 4 UNITS OF BATCH NUMBER 4190004, AND 1 UNIT FOR EACH BATCH 4193133 AND 4190002. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613076 ↗
• MalfunctionOct 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WERE PARTICLES AND FOREIGN BODIES OBSERVED IN 64 UNITS ON LOT NUMBER 4150858, AND 1 UNIT FOR BATCHES 4197890 AND 4199479. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20454910 ↗
• MalfunctionApr 18, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE TUBE CAP BECAME DISCONNECTED AND REMAINED IN THE SOCKET. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19133238 ↗
• MalfunctionApr 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THAT BLOOD IS GUSHING AND LEAKING OUT FROM THE PRODUCT WINGS. THIS OCCURRED IN 10 TUBES AND NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19010582 ↗
• MalfunctionMar 11, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, BLOOD LEAKED OUT OF THE SAFETY CAP OF THE WINGSET DURING USE. NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18880064 ↗
• MalfunctionJan 17, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE BLOOD WAS LEAKING OUT OF THE SAFETY CAP OF THE WINGSET. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527176 ↗