BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder 367352Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 30382903673521), received between Nov 3, 2017 and May 6, 2024 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE SLEEVE REMAINED IN VACUTAINER TUBE AFTER IT WAS REMOVED FROM THE HOLDER. NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249988 ↗
• MalfunctionApr 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THAT THERE WAS BLOOD LEAKAGE. PERSONNEL WAS WEARING APPROPRIATE PPE AND NONE GOT DIRECT EXPOSURE TO BLOOD. NO PATIENT IMPACT. THIS OCCURRED 10 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020728 ↗
• MalfunctionMar 28, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THAT BLOOD IS LEAKING DURING BLOOD COLLECTION. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990497 ↗
• MalfunctionOct 25, 2023Filling Problem; Filling Problem

  IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THAT THE BLOOD MOVED SLOWLY. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " SM 367352_3066880 BLOOD IS GOING SLOWLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007275 ↗
• InjuryFeb 27, 2023Physical Resistance/Sticking; Separation Problem; Physical Resistance/Sticking; Separation Problem

  IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER WHEN THE BUTTON WAS PRESSED TO RETRACT THE NEEDLE THE NEEDLE SEPARATED AND HIT THE PATIENT AND THE NURSE. BLOOD TESTS TO CHECK FOR INFECTION WAS PERFORMED ON THE PATIENT AND THE NURSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED USING THE BUTTERLY TO DRAW BLOOD FROM RIGHT AC, SHE DREW TWO TUBES. AS SOON AS SHE TOUCHED THE BUTTON TO RETRACT THE NEEDLE, THE NEEDLE BOUNCED BACK HIT PATIENT ON FOREARM AND HIT NURSE ON THE THUMB. NURSE WASHED AFFECTED AREAS ON NURSE AND PATIENT WITH SOAP AND WATER. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? NO DID EXPOSURE TO BLOOD/ BF OCCUR? YES IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? YES, BLOOD WAS DRAWN ON PATIENT AND NURSE TO CHECK FOR INFECTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16448354 ↗
• MalfunctionMar 2, 2020Break; Break

  IT HAS BEEN REPORTED THAT ONE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAS BEEN FOUND WITH THE CANNULA BREAKING OFF DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED NEEDLE BROKE DURING BLOOD COLLECTION. VERBIAGE RECEIVED, - BD VACUTAINER SET WITH REATTACHED HOLDER CONTAINING 21G X 3/4 INCH X 12 INCH BUTTERFLY ATTACHMENT LOT #8323548, EXP 11/30/2020: DURING VENIPUNCTURE THE NEEDLE (METAL PORTION) BROKE OFF AND HAD TO BE RETRIEVED FROM ENTRANCE TO VEIN WITH FORCEPS. METAL PORTION OF VACUTAINER REMOVED INTACT. PT HAD BRIEF SYNCOPAL RESPONSE TO THIS EVENT. PT DECLINED ULTRASOUND TO ASSESS FOR ANY REMAINING FOREIGN BODY. PT REPORTS NO SYMPTOMS OTHER THAN MILD BRUISE AT SITE OF VEINPUNCTURE, STATES THAT HE FEELS WELL ON F/U CALL. PRODUCT DISCARDED INTO SHARPS CONTAINER AT THE TIME OF THE EVENT.

  Patient problems: Bruise/Contusion

  MAUDE report 9775026 ↗
• MalfunctionFeb 12, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER LEAKED AIR FROM THE TUBING DURING VENIPUNCTURE. THIS OCCURRED ON 3 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331296 ↗
• MalfunctionJun 14, 2018Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAD A PINCHED TUBE THAT DECREASED BLOOD FLOW. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602173 ↗
• MalfunctionMay 16, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿THE TUBING WAS CUT.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7519102 ↗
• MalfunctionApr 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER HAD SEVERED TUBING, WHICH COULD LEAD TO A LEAK. NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7438045 ↗
• MalfunctionMar 22, 2018Material Protrusion/Extrusion; Scratched Material

  IT WAS REPORTED THAT BEFORE USE A BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE WAS FOUND WITH ¿A VERY SHARP PLASTIC PROTRUSION AT ONE SIDE OF THE VACUTAINER BASE, WHERE WE ANCHOR THE FINGERS WHEN PUSHING THE TUBE.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7363279 ↗
• MalfunctionDec 13, 2017Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED THAT THE TUBING OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WAS LEAKING. ANOTHER SET HAD A HOLE IN THE HOLDER AND ANOTHER SET HOLDER WAS DAMAGED. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7115463 ↗
• MalfunctionDec 8, 2017Leak/Splash

  IT WAS REPORTED THAT THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET IS CUT IN HALF UPON OPENING THE EDGES. WHEN BLOOD IS DRAWN IT IS SEEPING OUT THE EDGES OF THE BUTTERFLY. NO MEDICAL INTERVENTION OR INJURY REPORTED.

  Patient problems: Blood Loss

  MAUDE report 7100610 ↗
• MalfunctionDec 5, 2017Defective Component; Scratched Material

  IT WAS REPORTED THAT A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS WITH PRE-ATTACHED HOLDER HAD EXTRA, SHARP PLASTIC AROUND THE BEIGE HUB. THIS WAS OBSERVED FROM TWO SAMPLES. THERE IS A THIRD SAMPLE THAT HAS BEEN CIRCLED FOR A PLASTIC MOLDING DEFECT. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7085783 ↗
• MalfunctionDec 5, 2017Break

  IT WAS REPORTED THAT A CRIMP IN BETWEEN THE NEEDLE AND HOLDER, CAUSED THE TUBING OF THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET TO BREAK APART DURING A PHLEBOTOMY PROCEDURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085766 ↗
• MalfunctionDec 5, 2017Break

  IT WAS REPORTED THAT THERE WERE SEVERAL BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PREATTACHED HOLDER WITH BROKEN TUBING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7083650 ↗
• MalfunctionNov 28, 2017Break

  IT WAS REPORTED THAT A CRIMP IN BETWEEN THE NEEDLE AND HOLDER, CAUSED THE TUBING OF THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET TO BREAK APART DURING A PHLEBOTOMY PROCEDURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7064758 ↗
• MalfunctionNov 28, 2017Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED THAT THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET HAD A HOLE IN THE TUBING BETWEEN THE NEEDLE AND HOLDER CAUSING BLOOD SPRAY DURING A PHLEBOTOMY PROCEDURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7064268 ↗
• InjuryNov 27, 2017Retraction Problem

  IT WAS REPORTED THAT DURING USE, A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET DID NOT RETRACT ITS NEEDLE WHEN THE SAFETY WAS ACTIVATED. THE USER WAS PRICKED AS A RESULT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7059307 ↗
• MalfunctionNov 27, 2017Fluid/Blood Leak; Defective Component

  IT WAS REPORTED THAT 21 G X .75 IN. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH 12 IN. TUBING AND PRE-ATTACHED HOLDER HAS DEFECTIVE TUBING. THE TUBING THAT ATTACHES FROM THE NEEDLE TO THE HOLDER HAS EITHER, THE TUBING SLICED IN HALF, THE HOSE SMASHED IN MIDDLE OR THE BLOOD FLOWS OUT OF THE TUBING WHEN DRAWING FROM PATIENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7059023 ↗
• MalfunctionNov 27, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WAS PARTIALLY CUT WHICH RESULTED IN BLOOD LEAKING DURING THE COLLECTION PROCESS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7058990 ↗
• MalfunctionNov 3, 2017Fluid/Blood Leak; Torn Material

  IT WAS REPORTED THAT WHILE A NURSE WAS USING THE WINGSET PBBCS 21 X .75 12 PRE-ATTACHED TO DRAW BLOOD THERE WAS BLOOD LEAKAGE OUT OF THE TUBING. UPON EXAMINATION, TUBING WAS FOUND TO BE DEFECTIVE WITH VISIBLE SEVERED SLICED TUBING. THERE WERE TWO SEPARATE INCIDENTS: ONE IN WHICH THE LEAKING BLOOD CONTACTED A NURSE'S GLOVED HANDS AND A SECOND INCIDENT WHEN THE BLOOD LEAKED ON THE NURSE'S WATCH AND ARM. NO BLOOD EXPOSURE TO OPEN SKIN OR MUCOSAL MEMBRANES. NO INJURE OR MEDICAL INTERVENTION.

  Patient problems: Exposure to Body Fluids

  MAUDE report 6999664 ↗
• MalfunctionNov 3, 2017Bent; Break

  IT WAS REPORTED THAT BEFORE USING THE WINGSET PBBCS 21 X .75 12 PREATTACHED THE USER NOTED THAT THE TUBING WAS PINCHED AND SOMETIMES COMPLETELY SEVERED.

  Patient problems: No Information

  MAUDE report 6999550 ↗