BD Vacutainer® SPS Blood Collection Tubes for Microbiological Studies 364960Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 30382903649601), received between Apr 13, 2018 and Jul 6, 2022 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2022Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES THE TUBE WAS USED AFTER EXPIRATION AND MIXED PRODUCT IN A PACK. THE EXPIRED PRODUCT EVENT OCCURRED 1 TIME. THE MIXED PRODUCT EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE "RECEIVED A PACKAGE WITH TWO DIFFERENT LOT NUMBERS AND EXPIRED TUBES MIXED IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940064 ↗
• InjuryFeb 8, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES, THE USER EXPERIENCED INFLAMMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT PLASMA WAS INJECTED INTO THE PATIENTS FACE AND HER FACE SWELLED UP. CUSTOMER CALLED TO REPORT THAT THEY USED TUBE (B)(4) TO EXTRACT PRP, SHE SAID THEY DRAW THE BLOOD AND SPIN IT DOWN AND THEN INJECT IT INTO THE PATIENTS FACE, THE PATIENTS INSTANTLY HAD SWELLING IN THE FACE. SHE WAD PRESCRIBED PREDNISONE BUT SHE WAS STILL VERY SWOLLEN.

  Patient problems: Swelling/ Edema

  MAUDE report 13486927 ↗
• MalfunctionOct 11, 2021Delivered as Unsterile Product; Incorrect, Inadequate or Imprecise Result or Readings; Delivered as Unsterile Product; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES THERE WAS ERRONEOUS RESULTS AND STERILITY (PRODUCT NOT STERILE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT IS REPORTED CUSTOMER EXPERIENCED A FALSE POSITIVE AND STERILITY ISSUES. "BD SPS YELLOW TOP TUBES ARE USED FOR STERILITY TESTING OF CELLULAR THERAPY PRODUCTS. PRODUCTS COLLECTED SHOWED POSITIVE STERILITIES OF GRAM POSITIVE RODS. AFTER SENDING THE BLANK SPS TUBE LOT OF STERILITY TESTING, GRAM POSITIVE RODS WERE ALSO FOUND. THE TUBES HAVE CAUSED REPORTING OF MULTIPLE FALSE POSITIVE RESULTS DUE TO IT NOT BEING STERILE; 13 PRODUCT SAMPLES COLLECTED HAVE TESTED POSITIVE FOR BACILLUS AND/OR CORYNEFORM BACTERIA. FDA SAFETY REPORT ID# (B)(4)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611255 ↗
• MalfunctionSep 17, 2021Delivered as Unsterile Product; Incorrect, Inadequate or Imprecise Result or Readings; Delivered as Unsterile Product; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES, THE DEVICE EXPERIENCED STERILITY ISSUES (PRODUCT NOT STERILE), AND ERRONEOUS RESULTS. THE STERILITY EVENT OCCURRED 13 TIMES. ERRONEOUS RESULTS: NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE UCLA STEM CELL LAB HAD A RECENT INCREASE IN POSITIVE STERILITIES USING THE YELLOW TOP SPS TUBES. DURING THE INVESTIGATION, THE SPS TUBES WERE TESTED FOR STERILITY WITHOUT ANY MANIPULATION AND WERE FOUND TO BE POSITIVE FOR BACILLUS. THE SAMPLES THAT ARE SENT FOR STERILITY TESTING USING THESE TUBES ARE STERILE CRITICAL PRODUCTS SO THE HIGH NUMBER OF FALSE POSITIVES HAS CAUSED MANY PROBLEMS. THE TUBE LOT HAS BEEN QUARANTINED AND WE HAVE NOT HAD ANY POSITIVE STERILITIES SINCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490212 ↗
• MalfunctionJun 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED DURING USE THE BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED SHE USED AN EXPIRED TUBE. CUSTOMER WAS INQUIRING OF THE AFFECTS OF USING AN EXPIRED TUBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10185565 ↗
• MalfunctionJun 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT SEVERAL TUBES ARE UNDER FILLING WITH AN BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED SEVERAL LOTS OF SODIUM CITRATE THAT ARE UNDER FILLING. NOT SURE WHETHER IT¿S A USER ERROR OR TUBE ISSUE. HE STATED THAT IT IS A GENERAL OBSERVATION OVER MULTIPLE LOT NUMBERS WHEN IT¿S GETTING CLOSE TO THE END OF THE SHELF LIFE. IT HAS NOT BEEN REPORTED TO BD IN THE PAST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10164257 ↗
• MalfunctionJul 31, 2019Leak/Splash; Device Contamination with Body Fluid; Leak/Splash; Device Contamination with Body Fluid

  IT WAS REPORTED THAT THE BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDY EXPERIENCED A CRACKED TUBE, LEAKAGE, AND BLOOD POOLING IN THE STOPPER WELL AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 364960 BATCH NO. UNKNOWN. 7/16/2019- REACHED OUT TO CUSTOMER VIA PHONE TO CLARIFY COMPLAINT INFORMATION: CUSTOMER STATED THEY RECEIVED THE PACKAGE WITH THE BROKEN SHIPMENT AND STATED THEY HAVE PREVIOUSLY RECEIVED BOXES LIKE THIS BUT HAVE NOT REPORTED THE PROBLEM AND IS UNAWARE OF DATES OF EVENT OR LOTS AFFECTED. CUSTOMER ALSO STATED FOR THE INCIDENT ON 7/11/2019 (ONE OF THE NURSES PUT THE LABEL ON AND THE TUBE STARTED LEAKING AROUND THE TOP NEAR THE EDGE/WHERE THE YELLOW STOPPER GOES) SHE IS UNWARE OF THE LOT NUMBER, NO ADVERSE EVENTS. EMAIL: THE RESEARCH FACILITY QUALITY ASSURANCE TEAM CALLED THE CUSTOMER AND THE CUSTOMER STATED THAT YESTERDAY ((B)(6) 2019), THEY USED THE PRODUCT TO DRAW A PATIENT¿S BLOOD. ONE OF THE NURSES PUT THE LABEL ON AND THE TUBE STARTED LEAKING AROUND THE TOP NEAR THE EDGE/WHERE THE YELLOW STOPPER GOES. THE CUSTOMER DOES NOT KNOW WHICH LOT OR SHIPMENT IT CAME FROM. ALLEGATION: CUSTOMER WAS DRAWING BLOOD AND T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8845880 ↗
• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED THAT THE TUBES WERE BROKEN WHEN RECEIVED WITH A BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 3) CUSTOMER STATED THEY RECEIVED THE PACKAGE WITH THE BROKEN SHIPMENT FROM LOT NUMBER 9036707 ON 6/20/2019 AND STATED THEY HAVE PREVIOUSLY RECEIVED BOXES LIKE THIS BUT HAVE NOT REPORTED THE PROBLEM AND IS UNAWARE OF DATES OF EVENT OR LOTS AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836781 ↗
• MalfunctionJul 29, 2019Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING THE BLOOD DRAW, THE BD VACUTAINER® BLOOD COLLECTION TUBE FOR MICROBIOLOGICAL STUDIES CRACKED WHILE PUTTING THE STOPPER IN AND BROKE, CAUSING BLOOD TO GO "EVERYWHERE". THE NURSE WAS REPORTEDLY WEARING GLOVES AND WAS NOT INJURED BY THE BROKEN GLASS NOR EXPOSED TO THE BLOOD SPILT ON HER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER STATED THEY RECEIVED THE ONE PACK OF 100, SOME OF WHICH WERE BROKEN. NORMALLY, THEY JUST TAKE OUT THE BROKEN ONES AND KEEP THE REST. THE CUSTOMER STATED THAT THE DAY BEFORE THEY RECEIVED THIS BROKEN SHIPMENT, ONE OF THE NURSES WAS DRAWING BLOOD USING THE SAME PRODUCT, AND WHEN THE NURSE WAS PUTTING THE STOPPER IN, THE TUBE WAS CRACKED ON THE TOP AND BROKE, AND BLOOD WENT EVERYWHERE. THE CUSTOMER CONFIRMED THAT THE NURSE WAS NOT INJURED AND NO ADDITIONAL MEDICAL ATTENTION WAS REQUIRED. THE NURSE WAS WEARING GLOVES."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836538 ↗
• MalfunctionOct 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WITH THE USE OF THE BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES ERRONEOUS TEST RESULTS WERE OCCURING. 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 7960432 ↗
• MalfunctionJun 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES DID NOT WORK FOR MICROBIOLOGY. 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 7578681 ↗
• MalfunctionMay 9, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES WERE PRODUCING ERRONEOUS RESULTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500601 ↗
• MalfunctionApr 13, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES HAS MISMATCHED LABEL INFORMATION BETWEEN THE BOX LABEL AND THE PRODUCT INSIDE. THIS WAS NOTICED BEFORE USE AND NO INJURY OR MEDICAL INTERVENTIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427929 ↗