BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder 368652Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 30382903686521), received between Nov 4, 2017 and Aug 27, 2026 — classified as 2 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (36 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Report 2 of 2:It was reported while using BD Vacutainer® Safety-Lok¿ Blood Collection Set Pre-Attached Holder, an unspecified number of devices are separating where the tubing on the back of the device is coming off the back of the needle. Leakage was also observed. There was no health impact or consequences reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479607 ↗
• MalfunctionApr 14, 2026Short Fill; Difficult or Delayed Activation

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE SAFETY OF AN UNSPECIFIED NUMBER OF DEVICES IS EITHER DIFFICULT TO ENGAGE OR WILL NOT COVER THE NEEDLE TIP. ADDITIONALLY, AN UNSPECIFIED NUMBER OF DEVICES EXHIBITED INSUFFICIENT BLOOD FLOW. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876207 ↗
• MalfunctionFeb 4, 2026Device Markings/Labelling Problem

  IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE INCORRECT GTIN WAS PRINTED ON THE PACKAGING LABEL. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259717 ↗
• MalfunctionJan 27, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE USING ONE (1) CARTON OF THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE BARCODE PRINTED ON THE PACKAGING CORRESPONDS TO A DIFFERENT PRODUCT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189685 ↗
• MalfunctionDec 15, 2025Crack; Crack

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THERE WAS A CRACK IN THE PLASTIC OF THE SLBCS NON PATIENT NEEDLE END. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811807 ↗
• MalfunctionSep 16, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE RUBBER SLEEVE INSIDE THE HOLDER CAME OFF, CAUSING BLOOD TO LEAK. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067442 ↗
• MalfunctionAug 26, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE CUSTOMER NOTICED CRACKED SAFETY CLOSURES ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896819 ↗
• MalfunctionAug 26, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE CUSTOMER NOTICED CRACKED SAFETY CLOSURES ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896789 ↗
• MalfunctionAug 26, 2025Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE CUSTOMER NOTICED CRACKED SAFETY CLOSURES ON UNSPECIFIED NUMBER OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22894753 ↗
• MalfunctionJul 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER THERE WAS UNSPECIFIED SAMPLE LEAKAGE FROM 3 DEVICES. RECOLLECTION WAS REQUIRED. NO ADDITIONAL ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646750 ↗
• InjuryJul 21, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE NURSE OBTAINED DIRTY NEEDLESTICK INJURY WHEN A PREVIOUSLY DISCARDED BLOOD COLLECTION SET CAUGHT UP IN THE PLASTIC WINGS THAT ARE MOLDED INTO THE LID AND THE EXPOSED NEEDLE WAS PROTRUDING FROM THE CONTAINER. FIRST AID AND MEDICAL FOLLOW-UP STEPS WERE TAKEN, INCLUDING HIV, HEP B, AND HEP C TESTING AND REFERRAL TO INFECTIOUS DISEASES. REPORTED VERBATIM: IT WAS REPORTED THAT DURING A ROUTINE VENIPUNCTURE, THE RN DISPOSED OF THE USED BLOOD COLLECTION SET INTO A BD SHARPS COLLECTOR, PORTABLE (REF 303205) CONTAINER LOCATED IN THE PARTICIPANT¿S ROOM. A PREVIOUSLY DISCARDED BLOOD COLLECTION SET BD SAFETY-LOK¿ BLOOD COLLECTION SET 368652 HAD BEEN CAUGHT UP IN THE PLASTIC WINGS THAT ARE MOLDED INTO THE LID AND THE EXPOSED NEEDLE WAS PROTRUDING FROM THE CONTAINER. NOTING THAT THE SAFETY-LOK HAD NOT BEEN ACTIVATED AFTER COMPLETING A PREVIOUS BLOOD DRAW. AS A RESULT, THE RN SUSTAINED A NEEDLESTICK INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22557562 ↗
• MalfunctionOct 3, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE CUSTOMER NOTICED THE BLOOD IS MIXED WITH AIR IN AREAS WHERE BLOOD DOES NOT NORMALLY ENTER ON ONE (1) DEVICE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359450 ↗
• InjurySep 12, 2024Product Quality Problem; Physical Resistance/Sticking; Product Quality Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE SAFETY SHIELD FELL OFF WHEN THE CUSTOMER TRIED TO DISCARD THE USED NEEDLE CAUSING A NEEDLESTICK INJURY AND BLOOD EXPOSURE WITH (1) DEVICE. THE STAFF WAS TESTED FOR HIV, HEP B AND HEP C PER THE FACILITY PROTOCOL, AND ALL RESULTS CAME BACK NEGATIVE. NO ADVERSE RESULTS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20204845 ↗
• MalfunctionSep 5, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE NEEDLE DIDN'T GO INTO THE PATIENT'S SKIN SMOOTHLY AND THE SHEATH STARTS TO RETRACT TO COVER THE NEEDLE WHILE STILL IN THE PATIENT'S VEIN ON (1) DEVICE. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152761 ↗
• MalfunctionSep 5, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET PRE-ATTACHED HOLDER, THE NEEDLE DIDN'T GO INTO THE PATIENT'S SKIN SMOOTHLY AND THE SHEATH STARTS TO RETRACT TO COVER THE NEEDLE WHILE STILL IN THE PATIENT'S VEIN ON (1) DEVICE. NO PATIENT OR USER IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152333 ↗
• MalfunctionJul 3, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER SAFETY-LOK BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, BLOOD LEAKED FROM THE ROOT OF THE WING OF THE NEEDLE MAKING A MESS AND CAUSING THE TUBE TO UNDERFILLED IN (23) DEVICES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669271 ↗
• MalfunctionJun 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE TUBE WAS DAMAGED, AND CAUSED BLOOD EXPOSURE. NO PATIENT IMPACT AS THE BLOOD ONLY LEAKED OUT IN A VERY SMALL AMOUNT, SO THERE WAS NO DIRECT CONTACT WITH THE SKIN OR OTHER PARTS OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506879 ↗
• MalfunctionMay 17, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE CUSTOMER SAW BLOOD LEAKAGE OCCUR IN THE TUBING AND A HOOKED NEEDLE POINT FOR 23 NEEDLES. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345190 ↗
• MalfunctionApr 15, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE HOLDER BROKE OFF AT THE ROOT DURING BLOOD COLLECTION. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104498 ↗
• MalfunctionDec 15, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THE RUBBER SLEEVE BROKE OFF DURING BLOOD COLLECTION. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18338138 ↗
• MalfunctionSep 6, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER AIR BUBBLES FORMED AND BLEW PATIENT'S VEIN. THERE WAS NO ADDITIONAL IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CAT # 368652 HAD STARTED DRAWING AIR WITH THE BLOOD, GOING SUPER, AND BLEW THE PATIENT'S VEIN

  Patient problems: Perforation of Vessels

  MAUDE report 17696059 ↗
• MalfunctionJul 21, 2023Short Fill; Short Fill

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER CUSTOMER REPORTS LOW DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED CUSTOMER PROBLEM: CUSTOMER IS REPORTING LOW DRAW VOLUME WITH PRODUCT 368652. LOT 2223194. THEY SEE THE FLASH AND THE BLOOD IS THERE BUT AS SOON AS THEY INSERT THE TUBE IT WOULD BE VERY SLOW TO DRAW AN ONLY FILL UP TO 0.5INCH OF THE TUBE. THEY HAVE TRIED MULTIPLE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374292 ↗
• MalfunctionMay 24, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER IT WAS DISCOVERED THAT THE IFU FOR THE DEVICE DOES NOT COMPLY WITH UKRAINIAN REQUIREMENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE DISCOVERED THAT SOME OF THE IFUS FOR IDS SM PRODUCTS ARE NOT COMPLIANT WITH UKRAINIAN REQUIREMENTS. IDS SM PRODUCTS OF HIGHER CLASSES WERE REGISTERED VIA CONFORMITY ASSESSMENT BODY IN UKRAINE. WHEN PRODUCT IS REGISTERED VIA CONFORMITY ASSESSMENT BODY IT IS REQUIRED TO HAVE IT INDICATED ON THE LABELS AND IFUS (CONFORMITY ASSESSMENT BODY NUMBER MUST BE PLACED ON THE LABELING) ¿ IT MUST BE PLACED UNDERNEATH THE UKRAINIAN CONFORMITY MARK UKRAINIAN CONFORMITY MARK: UKRAINIAN CONFORMITY MARK WITH CONFORMITY ASSESSMENT BODY NUMBER: AS AN EXAMPLE PLEASE SEE BELOW THE NEW IFU FOR SKU 367300 WHICH WAS REGISTERED VIA CONFORMITY ASSESSMENT BODY ¿ THERE IS NO UKRAINIAN CONFORMITY ASSESSMENT BODY NUMBER UNDERNEATH THE UKRAINIAN CONFORMITY MARK WHILE IT SHOULD BE INCLUDED. THIS IS CONSIDERED AS NON-CONFORMITY. ALSO, WE WOULD LIKE TO POINT OUT THAT IN THE PROCEDURE ¿MEDICAL DEVICE AND IN VITRO DIAGNOSTIC MEDICAL DEVICE REQUIRED LABE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000056 ↗
• MalfunctionOct 27, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER CUSTOMER HAS OBSERVED DEBRIS AND DIRT INSIDE THE SEALED DEVICE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER PROBLEM: CUSTOMER HAS OBSERVED DEBRIS AND DIRT INSIDE THE SEALED DEVICE 368652 WINGSET, SLBCS 21X.75 12 PREATTACHED LOT. 1285435 EXP 10/31/2023."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681883 ↗
• MalfunctionAug 14, 2022Device 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 THE CUSTOMER OBSERVED A DOUBTFUL VISUAL ASPECT ON SOME UNITS. THE VISIBLE ANOMALY ON THE PACKAGING OF THE PRODUCTS WAS OBSERVED DURING UNPACKING. THIS EVENT OCCURRED 1 TIME THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DOUBTFUL VISUAL ASPECT HAS BEEN OBSERVED ON SOME UNITS. THE VISIBLE ANOMALY ON THE PACKAGING OF THE PRODUCTS WAS OBSERVED DURING UNPACKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15222775 ↗