BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder 368656Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 30382903686569), received between Nov 3, 2017 and Aug 22, 2024 — classified as 1 injury, 71 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (28 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Fungus in Device Environment; Fungus in Device Environment

  IT WAS REPORTED BEFORE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, MOLD WAS OBSERVED IN THE PACKAGING AND IN THE WINGSET OF ONE (1) DEVICE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031454 ↗
• MalfunctionMay 18, 2022Retraction Problem; Retraction Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER , THE DEVICE EXPERIENCED DIFFICULTY WITH THE SAFETY FEATURE DURING USE. FOLLOW UP WAS REQUIRED THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT NEEDLE IS RETRACTING IN THE MIDDLE OF THE DRAW. FOLLOW UP REQUIRED Y/N?: Y NEEDLE RETRACTING MID-DRAW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431977 ↗
• MalfunctionApr 1, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE USER EXPERIENCED RETRACTION ISSUES. THE DEVICE DID NOT ENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT WINGSET IS NOT RETRACTING BLOOD. "CUSTOMER WANTED TO RETURN THE ITEM. SAID THAT ITEM IS NOT WORKING OR NOT EXTRACTING BLOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979801 ↗
• MalfunctionNov 13, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT WHILE DRAWING BLOOD AIR BUBBLE ARE FORMING WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THIS OCCURRED ON 12 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE ARE AIR BUBBLES IN TUBING WHILE DRAWING BLOOD WITH SYRINGE. THE DEPARTMENT IS LABOR AND DELIVERY AND SPECIFICALLY DRAWING BLOOD FROM NEW BORN BABIES. ADDITIONALLY, ON 11/8/2019 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THERE LEAKING BETWEEN THE SYRINGE AND TUBING? (THE COMPLAINT I SENT ON BEHAVE OF THE CUSTOMER DID NOT INCLUDING AND REFERENCE TO LEAKING?) WAS THE SYRINGE USED A BD PRODUCT? (YES THEY USE BD SYRINGES). WAS THE SYRINGE AND TUBING CONNECTED PROPERLY? (YES THE SYRINGE WAS ATTACHED PROPERLY). IT STATES THE INCIDENT HAS OCCURRED 12 TIMES, ARE YOU ABLE TO PROVIDE DATES AND/OR PATIENT IDENTIFIERS? (THE NUMBER 12 WAS AN ESTIMATE I MADE BASED ON MY CONVERSATION WITH THE CUSTOMER AND SOME OF THE NURSING STAFF. THEY CONVERTED TO PUSH BUTTON PAH IN SEPTEMBER AND THE LABOR AND DELIVERY DEPARTMENT / NEW BABY NURSERY SAID THAT T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9316419 ↗
• MalfunctionOct 24, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 368656, MATERIAL NO. 9150607. IT IS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPLATTER WAS INSIDE HOLDER AND LEAKAGE WAS WITNESSED UNDER BLUE WINGS AFTER BLOOD DRAW WAS COMPLETE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A DROP OF BLOOD WAS NOTICED ON THE HUB WHILE BEING USED. AND WHEN THE NEEDLE WAS TOOK OUT, BLOOD WAS ALSO NOTICED UNDER THE WINGS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9233874 ↗
• MalfunctionOct 23, 2019Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings; Leak/Splash; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER EXPERIENCED BLOOD SPATTER/LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368656 BATCH NO. 9158903. THE NEEDLE WAS LEAKING WHERE IT ATTACHES TO THE HOLDER. HAD NEVER SEEN THIS BEFORE. SEEMED LIKE THE TUBES HAD AIR IN THEM AS WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9225239 ↗
• MalfunctionOct 8, 2019Product Quality Problem; Product Quality Problem

  IT HAS BEEN REPORTED THAT ONE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WINGSET FELL APART. EVENT DESCRIPTION STATES, "368656 WINGSET FELL APART DURING USE", "PUSH BUTTON WINGSET FELL APART."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9168743 ↗
• MalfunctionOct 4, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT RETRACTION FAILURE OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PROVIDER WAS DRAWING LAB-WORK AND AS SHE ATTEMPTED TO RETRACT THE BUTTERFLY NEEDLE AFTER DRAWING BLOOD, THE DEVICE DOES NOT RETRACT AND THE NEEDLE AND SPRING IN THE DEVICE DOES NOT ENGAGE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158230 ↗
• MalfunctionSep 18, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT A RETRACTION ISSUE OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CUSTOMER STATED THAT SHE HAD TO REALLY PUSH DOWN IN ORDER FOR THE NEEDLE TO RETRACT AND IT RETRACTED VERY SLOWLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9083594 ↗
• MalfunctionAug 16, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT SEPARATION OCCURRED AFTER USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BUTTERFLY NEEDLE GAUGE 23 - NEEDLE IS COMING APART BEFORE AND AFTER USE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8903215 ↗
• MalfunctionAug 13, 2019Product Quality Problem; Product Quality Problem

  MATERIAL NO: 368656, BATCH NO: 9086811. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THE DEVICE WOULD SEPARATE LEAVING THE NEEDLE EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE DEVICE GETS SEPARATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8890800 ↗
• MalfunctionAug 12, 2019Product Quality Problem; Difficult or Delayed Activation; Product Quality Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE DEVICE FELL APART AFTER USE WHEN BUTTON WAS PUSHED TO RETRACT THE NEEDLE AND LEFT THE NEEDLE UNPROTECTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884648 ↗
• MalfunctionJul 31, 2019Leak/Splash; Product Quality Problem; Leak/Splash; Product Quality Problem

  IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER EXPERIENCED BLOOD SPATTER/LEAKAGE, AND HUB SEPARATION FROM THE DEVICE LEAVING THE NEEDLE EXPOSED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 368656; BATCH NO: 9091626. ACCOUNT COMPLAINS THAT THE DEVICE BROKE DURING RETRACTION THE CUSTOMER STATES THAT THE DEVICE "EXPLODED" DURING THE RETRACTION PROCESS AND ON OF THE PIECES HIT HER IN THE STOMACH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8845811 ↗
• MalfunctionJul 31, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS WITH PRE-ATTACHED HOLDERS EXPERIENCED HUB SEPARATION FROM THE DEVICE LEAVING THE NEEDLE EXPOSED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368656, BATCH NO. 9086812. 3 OF 4 COMPLAINTS. WE HAVE HAD THE SAME ISSUE WITH ANOTHER LOT OF BUTTERFLIES. THE ISSUE OF COMING APART BEFORE AND AFTER USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8845742 ↗
• MalfunctionJul 29, 2019Product Quality Problem; Product Quality Problem

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE REST OF THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WINGSET SEPARATES. 4 OF 4 COMPLAINTS OPENED FOR THE EXTRA DATES. WE HAVE HAD THE SAME ISSUE WITH ANOTHER LOT OF BUTTERFLIES. THE ISSUE OF COMING APART BEFORE AND AFTER USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8839318 ↗
• MalfunctionJul 29, 2019Product Quality Problem; Product Quality Problem

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE REST OF THE DEVICE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WING SET FELL APART AT THE HUB. ANOTHER LOT NUMBER DOING THE SAME AS BEFORE. THE WING-SET FALLING APART AT THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837012 ↗
• MalfunctionJul 26, 2019Product Quality Problem; Product Quality Problem

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS BEEN FOUND WITH THE HUB SEPARATING FROM THE REST OF THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE WINGSET SEPARATES. 2 OF 4 COMPLAINTS OPENED FOR THE EXTRA DATES. WE HAVE HAD THE SAME ISSUE WITH ANOTHER LOT OF BUTTERFLIES. THE ISSUE OF COMING APART BEFORE AND AFTER USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8834096 ↗
• MalfunctionJul 23, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER SEPARATED CAUSING THE NEEDLE TO BE EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368656 BATCH NO. 9091626. IT WAS REPORTED THAT TWO BUTTERFLIES FELL APART AND THE SPRING CAME APART EXPOSING THE NEEDLE. WE HAVE BUTTERFLY ISSUE, I GOT A BOX THAT JUST OPENED LOT# 9091626 TWO BUTTERFLY FELL APART, AS SOON AS YOU GRAB THE WINGS THE WHOLE MECHANISM AT THE BASE OF THE WINGS COME APART AND SPRING COMES APART EXPOSING THE NEEDLE. DATE OF EVENT IS UNKNOWN **POSSIBLY THE JUN 24TH** OCCURRENCE QTY: SEVERAL INCIDENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8819151 ↗
• MalfunctionJul 18, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE HUB SEPARATES FROM DEVICE DURING USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY COMPANY REPORTER: (4 OF 5). IT WAS REPORTED DEVICE IS BREAKING APART WHEN ACTIVATING RETRACTION BUTTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WERE APPROXIMATELY SIX OCCURRENCES OF THE BARREL BREAKING APART DURING THE RETRACTION PROCESS FOLLOWING THE VENIPUNCTURE PROCESS. APPROXIMATELY THREE DIFFERENT PHLEBOTOMISTS EXPERIENCED THIS ISSUE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804602 ↗
• MalfunctionJul 18, 2019Product Quality Problem; Product Quality Problem

  IT HAS BEEN REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS HUB SEPARATION FROM THE DEVICE DURING/AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED DEVICE IS BREAKING APART WHEN ACTIVATING RETRACTION BUTTON. DETAILED SAFETY ISSUE VERBIAGE, - "THERE WERE APPROXIMATELY SIX OCCURRENCES OF THE BARREL BREAKING APART DURING THE RETRACTION PROCESS FOLLOWING THE VENIPUNCTURE PROCESS. APPROXIMATELY THREE DIFFERENT PHLEBOTOMISTS EXPERIENCED THIS ISSUE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804099 ↗
• MalfunctionJul 16, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE HUB SEPARATED FROM THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER DURING USE WHILE RETRACTING THE NEEDLE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 5TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WERE APPROXIMATELY SIX OCCURRENCES OF THE BARREL BREAKING APART DURING THE RETRACTION PROCESS FOLLOWING THE VENIPUNCTURE PROCESS. APPROXIMATELY THREE DIFFERENT PHLEBOTOMISTS EXPERIENCED THIS ISSUE." CURRENTLY WE HAVE HAD APPROXIMATELY 20 DIFFERENT OCCURRENCES WITH THE 23G BUTTERFLY WITH THE PRE-ATTACHED HUB BREAK A PART. DATES OF THE EVENTS: (B)(6) 2019, (B)(6) 2019, (B)(6) 2019,(B)(6) 2019, AND (B)(6) 2019. THE DEPARTMENTS INVOLVED ARE INPATIENT PHLEBOTOMY, OUTPATIENT PHLEBOTOMY, AND THE EMERGENCY ROOM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8794743 ↗
• MalfunctionJul 15, 2019Product Quality Problem; Product Quality Problem

  MATERIAL NO. 368656 BATCH NO. 9086812. IT WAS REPORTED THAT BEFORE AND AFTER USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THE WINGSET SEPARATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD THE SAME ISSUE WITH ANOTHER LOT OF BUTTERFLIES. THE ISSUE OF COMING APART BEFORE AND AFTER USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8791635 ↗
• MalfunctionJul 10, 2019Product Quality Problem; Difficult or Delayed Activation; Product Quality Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHEN THE SAFETY BUTTON WAS PUSHED TO RETRACT THE NEEDLE, THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER FELL APART AT THE HUB DURING USE. THE CUSTOMER REPORTED 2 OCCURRENCES OF THIS EVENT, AND THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT 368656, LOT #: 9091626 THE PRE-ATTACHED CAME APART WHILE DRAWING BLOOD. ON TWO SEPARATE OCCASIONS, WHEN BUTTON IS PUSHED TO RETRACT THE NEEDLE THE DEVICE FALLS APART AND LEAVES THE NEEDLE UNPROTECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778502 ↗
• MalfunctionJul 10, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT FOUR BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDERS EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBIAGE RECEIVED, PRODUCT # 368656, LOT # 9091626 CAME APART WHEN DRAWING BLOOD. ADDITIONAL INFORMATION RECEIVED, THAT IS THE CORRECT PRODUCT NUMBER. THE ISSUES STARTED TO OCCUR APPROXIMATELY TWO WEEKS AGO GIVE OR TAKE A FEW DAYS. I WAS MADE AWARE OF THE SITUATION LAST FRIDAY THE 21ST OF JUNE. SINCE THEN, FOUR PHLEBOTOMISTS HAVE COME FORWARD TO COMPLAIN ABOUT BUTTERFLIES COMING APART EITHER PRIOR TO PERFORMING BLOOD DRAWS OR AT THE END WHEN ENGAGING THE SAFETY BUTTON. I HAVE THE PRODUCT IN QUESTION BUT UNFORTUNATELY I DO NOT HAVE PICTURES AT THIS TIME. I WILL BE CC-ING MY DIRECTOR AND OUR QUALITY CONTROL MANAGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8776861 ↗
• MalfunctionJul 10, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE WHEN BUTTON IS PUSHED TO RETRACT THE NEEDLE, THE DEVICE SEPARATES AND NEEDLE IS LEFT UNPROTECTED WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2) . ON TWO SEPARATE OCCASIONS WHEN BUTTON IS PUSHED TO RETRACT THE NEEDLE, THE DEVICE FALLS APART AND LEAVES THE NEEDLE UNPROTECTED WHILE DRAWING BLOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8776754 ↗