BD Vacutainer® Serum 10.0 mL 368045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903680451), received between Sep 14, 2018 and Aug 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IT WAS REPORTED THAT AFTER CENTRIFUGATION WITH 20 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES RBCS ARE CLOUDING IN SUPERNATANT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES RBCS ARE CLOUDING IN SUPERNATANT AFTER CENTRIFUGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561169 ↗
• MalfunctionJun 15, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED WHEN USING THE BD VACUTAINER® UNSPECIFIED BD VACUTAINER TUBE PLN PLC 16X100MM 10.0ML PLBL RD, THE USER NOTICED THE TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: VERBIAGE RECEIVED: "IT WAS FOUND OUT THAT EXPIRED BLOOD COLLECTION TUBES WERE USED TO COLLECT BLOOD FROM PATIENTS. WOULD YOU PLEASE LET US KNOW IF THIS WILL AFFECT OUR SAMPLE QUALITY?" ADDITIONAL INFORMATION RECEIVED 2021-06-09 12:31 PM: WAS THE PATIENT REDRAWN AND RE TESTED? NO. WHAT WAS THE RESULTS OF THE REPEAT TESTING? N/A. WAS THERE ANY MEDICAL INTERVENTION DUE TO ERRONEOUS RESULTS? N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001029 ↗
• MalfunctionSep 14, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7876891 ↗